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Completed

NCT Number: NCT05021757

Disrupt CAD III Post-Approval Study (PAS)

The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Washington D.C., District of Columbia, 20037, United States

About this study

Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers [PPM] or implantable cardioverter defibrillators [ICDs]) will be enrolled. Subjects will be followed through discharge.

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
  • Left ventricular ejection fraction >25% within 6 months
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • LAD, RCA or LCX (or of their branches) with:
  • Stenosis of ≥70% and <100% or
  • Stenosis ≥50% and <99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  • 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 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

Exclusion criteria

  • Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
  • New York Heart Association (NYHA) class III or IV heart failure
  • Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • Subjects in cardiogenic shock or with clinical evidence of acute heart failure
  • 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 target lesion (in-stent restenosis)

Treatment and study plan

Shockwave C2 Coronary IVL

Device

PCI procedure using a Shockwave C2 coronary IVL catheter

Primary outcomes

  1. All-cause Death Rate

    Time frame: Up to hospital discharge, approximately 24-48 hours

  2. Number of Participants With Procedure-related Adverse Events

    Time frame: Up to hospital discharge, approximately 24-48 hours

  3. Number of Participants With IVL-related Ventricular Arrhythmia

    Time frame: Up to hospital discharge, approximately 24-48 hours

  4. Number of Participants With IVL Balloon Loss of Pressure/Rupture

    Time frame: Up to hospital discharge, approximately 24-48 hours

  5. Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture

    Time frame: Up to hospital discharge, approximately 24-48 hours

  6. Number of IVL-related Pacing Issues in Patients With PPM/ICD

    Time frame: Up to hospital discharge, approximately 24-48 hours

    Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).

Sponsors and collaborators

Lead sponsor

Shockwave Medical, Inc.

Industry

Registry information

Official study title

New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2021
Registry last updated
Feb 1, 2024

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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