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Completed

NCT Number: NCT03595176

Disrupt CAD III With the Shockwave Coronary IVL System

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur, Toulouse, Cedex 3, France

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About this study

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is ≥18 years of age
  • Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  • For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
  • For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
  • If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure (note: if both labs are drawn, both must be normal).
  • If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment (note: CK-MB is required if drawn from the sheath).
  • Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
  • Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  • Lesions in non-target vessels requiring PCI may be treated either:
  • >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
  • >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
  • >30 days after the study procedure

Angiographic Inclusion Criteria

  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
  • Stenosis of ≥70% and <100% or
  • Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • The lesion length must not exceed 40 mm
  • The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
  • Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
  • Ability to pass a 0.014" guide wire across the lesion

Exclusion criteria

  • Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  • Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
  • Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  • Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory's upper limit of normal
  • New York Heart Association (NYHA) class III or IV heart failure
  • Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) > 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
  • Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • Subjects with a life expectancy of less than 1 year
  • Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
  • Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  • High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
  • Unprotected left main diameter stenosis >30%
  • Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  • Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Previous stent within the target vessel implanted within the last year
  • Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Treatment and study plan

Lithotripsy

Device

Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Primary outcomes

  1. Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

    Time frame: within 30 days of index procedure

    The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.

  2. Number of Participants With Procedural Success (Residual Stenosis <50%)

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

    The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.

Secondary outcomes

  1. Number of Participants With Device Crossing Success

    Time frame: at end of procedure

    Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  2. Number of Participants With Angiographic Success (Residual Stenosis <50%)

    Time frame: at end of procedure

    Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  3. Number of Participants With Procedural Success (Residual Stenosis <=30%)

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

    Procedural Success defined as stent delivery with a residual stenosis <=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  4. Number of Participants With Angiographic Success (Residual Stenosis <=30%)

    Time frame: at end of procedure

    Angiographic Success defined as stent delivery with <=30% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  5. Number of Participants With Serious Angiographic Complications

    Time frame: at end of procedure

    Serious Angiographic Complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  6. MACE Rate at 6 Months

    Time frame: within 6 months of index procedure

    MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  7. MACE Rate at 12 Months

    Time frame: within 12 months of index procedure

    MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  8. MACE Rate at 24 Months

    Time frame: within 24 months of index procedure

    MACE at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  9. Target Lesion Failure (TLF) Rate at 30 Days

    Time frame: within 30 days of index procedure

    Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  10. Target Lesion Failure (TLF) Rate at 6 Months

    Time frame: within 6 months of index procedure

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  11. Target Lesion Failure (TLF) Rate at 12 Months

    Time frame: within 12 months of index procedure

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  12. Target Lesion Failure (TLF) Rate at 24 Months

    Time frame: within 24 months of index procedure

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  13. All-Cause Death Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  14. All-Cause Death Rate at 6 Months

    Time frame: within 6 months of index procedure

    All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  15. All-Cause Death Rate at 12 Months

    Time frame: within 12 months of index procedure

    All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  16. All-Cause Death Rate at 24 Months

    Time frame: within 24 months of index procedure

    All-cause death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  17. Cardiac Death Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  18. Cardiac Death Rate at 6 Months

    Time frame: within 6 months of index procedure

    Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  19. Cardiac Death Rate at 12 Months

    Time frame: within 12 months of index procedure

    Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  20. Cardiac Death Rate at 24 Months

    Time frame: within 24 months of index procedure

    Cardiac death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  21. MI Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  22. MI Rate at 6 Months

    Time frame: within 6 months of index procedure

    MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  23. MI Rate at 12 Months

    Time frame: within 12 months of index procedure

    MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  24. MI Rate at 24 Months

    Time frame: within 24 months of index procedure

    MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  25. Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  26. TV-MI Rate at 6 Months

    Time frame: within 6 months of index procedure

    TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  27. TV-MI Rate at 12 Months

    Time frame: within 12 months of index procedure

    TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  28. TV-MI Rate at 24 Months

    Time frame: within 24 months of index procedure

    TV-MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  29. Procedural MI Rate at 30 Days

    Time frame: within 30 days of index procedure

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  30. Procedural MI Rate at 6 Months

    Time frame: within 6 months of index procedure

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  31. Procedural MI Rate at 12 Months

    Time frame: within 12 months of index procedure

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  32. Procedural MI Rate at 24 Months

    Time frame: within 24 months of index procedure

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  33. Non-Procedural MI Rate at 30 Days

    Time frame: within 30 days of index procedure

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  34. Non-Procedural MI Rate at 6 Months

    Time frame: within 6 months of index procedure

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  35. Non-Procedural MI Rate at 12 Months

    Time frame: within 12 months of index procedure

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  36. Non-Procedural MI Rate at 24 Months

    Time frame: within 24 months of index procedure

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  37. Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  38. ID-TVR Rate at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  39. ID-TVR Rate at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  40. ID-TVR Rate at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  41. Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  42. ID-TLR Rate at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  43. ID-TLR Rate at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  44. ID-TLR Rate at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  45. Non-ID-TVR Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  46. Non-ID-TVR Rate at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  47. Non-ID-TVR Rate at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  48. Non-ID-TVR Rate at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  49. Non-ID-TLR Rate at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  50. Non-ID-TLR Rate at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  51. Non-ID-TLR Rate at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  52. Non-ID-TLR Rate at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  53. Any Revascularizations Rate at 30 Days

    Time frame: within 30 days of index procedure

    Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  54. Any Revascularizations Rate at 6 Months

    Time frame: within 6 months of index procedure

    Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  55. Any Revascularizations Rate at 12 Months

    Time frame: within 12 months of index procedure

    Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  56. Any Revascularizations Rate at 24 Months

    Time frame: within 24 months of index procedure

    Any revascularizations (ID and non-ID) at 24 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  57. Stent Thrombosis Rate at 30 Days

    Time frame: within 30 days of index procedure

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  58. Stent Thrombosis Rate at 6 Months

    Time frame: within 6 months of index procedure

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  59. Stent Thrombosis Rate at 12 Months

    Time frame: within 12 months of index procedure

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  60. Stent Thrombosis Rate at 24 Months

    Time frame: within 24 months of index procedure

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  61. Rate of MI Using the 4th Universal Definition at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  62. Rate of MI Using the 4th Universal Definition at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  63. Rate of MI Using the 4th Universal Definition at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  64. Rate of MI Using the 4th Universal Definition at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  65. Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days

    Time frame: within 30 days of index procedure

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  66. Rate of MI Using the SCAI Definition at 6 Months

    Time frame: within 6 months of index procedure

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  67. Rate of MI Using the SCAI Definition at 12 Months

    Time frame: within 12 months of index procedure

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

  68. Rate of MI Using the SCAI Definition at 24 Months

    Time frame: within 24 months of index procedure

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Sponsors and collaborators

Lead sponsor

Shockwave Medical, Inc.

Industry

Registry information

Official study title

Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jul 23, 2018
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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