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Completed

NCT Number: NCT04865588

Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions

Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material. In rotational atherectomy, a rotating instrument is used to break up the calcification before a stent is placed and helps restore blood flow to the heart. However, severely calcified regions are difficult to treat and even after treatment arteries can re-clog and major cardiac events occur. This study will test if rotational atherectomy with the addition of a cutting balloon - a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs - will result in increased blood vessel lumen, more optimal stent expansion and decreased cardiac problems compared to current standard treatment.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Icahn School of Medicine at Mount Sinai, New York, United States

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About this study

This is a prospective, pilot study randomizing patients with stable Coronary Artery Disease undergoing Percutaneous Coronary Intervention for a de novo calcified lesion with drug eluting stent implantation to angioplasty with rotational atherectomy followed by cutting balloon (ROTA + CBA) or rotational atherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.

The clinical investigation will be conducted at 2 centers in the US. Up to 48 randomized subjects per site will be enrolled in this study. Subjects participating in this clinical investigation will be followed for 9 months. The expected duration of enrollment is approximately 6 months. The total duration of the clinical investigation is expected to be approximately 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults Patients ≥18 years of age
  • Patients undergoing percutaneous coronary intervention with planned rotational atherectomy and planned drug-eluting stent implantation of a lesion with target vessel reference diameter ≥2.5 mm and ≤ 4.0mm, lesion length ≥ 5 mm and moderate to severe calcification by angiography
  • Patients eligible for percutaneous coronary intervention

Exclusion criteria

  • Patients in cardiogenic shock
  • Planned surgery (cardiac and non-cardiac) within 6 months after the index procedure unless the dual-antiplatelet therapy can be maintained throughout the perisurgical period
  • Patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction
  • Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, < 2 years postmenopausal, or does not consistently use effective methods of contraception
  • Patient has any other serious medical illness (e.g., cancer, end-stage congestive heart failure) that may reduce life expectancy to less than 12 months
  • Currently participating in another investigational drug or device study
  • Patients referred to coronary artery bypass grafting after heart team discussion

Angiographic Specific Exclusion Criteria:

  • Lesion(s) with angulation > 45 degrees by visual estimate
  • Lesion(s) stenosis through which a guidewire will not pass.
  • Last remaining vessel with compromised (<30%) left ventricular function
  • Saphenous vein grafts
  • Angiographic evidence of thrombus
  • Angiographic evidence of significant dissection at the treatment site
  • Lesion(s) with previously placed stent within 10 mm (visual estimate)

Treatment and study plan

Rotational atherectomy

Procedure

angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification

Cutting Balloon

Device

a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs

plain old balloon

Device

current standard treatment of stent placement

Primary outcomes

  1. Minimum Stent Area After Percutaneous Coronary Intervention

    Time frame: Post-procedure, Day 0

    Post-procedure minimum stent area after percutaneous coronary intervention assessed by intravascular ultrasound (IVUS)

Secondary outcomes

  1. In-segment Minimum Lumen Area After Stent Implantation and Post Dilatation

    Time frame: Post-procedure, Day 0

    In-segment Minimum lumen area after stent implantation and post dilatation assessed by intravascular ultrasound

  2. Minimum Percent Stent Expansion After Percutaneous Coronary Intervention

    Time frame: Post-procedure, Day 0

    Minimum percent stent expansion after Percutaneous Coronary Intervention assessed by intravascular ultrasound

  3. Mean Percent Stent Expansion After Percutaneous Coronary Intervention

    Time frame: Post-procedure, Day 0

    Mean percent stent expansion after percutaneous coronary intervention assessed by intravascular ultrasound

  4. Number of Participants With Dissection After Percutaneous Coronary Intervention

    Time frame: Post-procedure, Day 0

    Number of Participants with Dissection after Percutaneous Coronary Intervention assessed by intravascular ultrasound.

  5. Number of Participants With Stent Malapposition After Percutaneous Coronary Intervention

    Time frame: Post-Procedure, Day 0

    Number of Participants with Stent malapposition after Percutaneous Coronary Intervention assessed by intravascular ultrasound. Malapposition is indicated by blood visible behind stent struts. Stents may be completely or only partially malapposed depending on how much of the stent is in contact with the lumen wall.

  6. Number of Participants With Dissection After Rotational Atherectomy and Cutting Balloon Angioplasty /Non-compliant Balloon Angioplasty (CBA/NCBA)

    Time frame: Post-CBA/NCBA before stent, Day 0

    Number of Participants with Dissection after Rotational atherectomy and cutting balloon angioplasty /non-compliant balloon angioplasty (CBA/NCBA) assessed by intravascular ultrasound. A dissection or tear in the vessel wall

  7. Number of Participants With a Calcium Fracture After Rotational Atherectomy and Cutting/Plain Old Balloon

    Time frame: Post-Procedure, Day 0

    Number of Participants with a Calcium fracture after Rotational atherectomy and Cutting/Plain old balloon assessed by intravascular ultrasound. A fracture within the calcified area.

  8. Acute Lumen Gain In-segment After Stent Implantation Assessed by Angiography

    Time frame: Post-procedure, Day 0

    Defined as the minimal luminal diameter in stent after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).

  9. Acute Lumen Gain In-stent After Stent Implantation Assessed by Angiography

    Time frame: Post-procedure, Day 0

    Defined as the minimal luminal diameter in segment after stent implantation minus the minimal luminal diameter at baseline (prior to percutaneous coronary intervention and/or prior to stent placement).

  10. Percent Residual Diameter Stenosis In-segment After Stent Implantation

    Time frame: Post-procedure, Day 0

    Percent Residual diameter stenosis in-segment after stent implantation assessed by Angiography

  11. Percent Residual Diameter Stenosis In-stent After Stent Implantation

    Time frame: Post-procedure, Day 0

    Percent Residual diameter stenosis in-stent after stent implantation assessed by Angiography

  12. Minimum Lumen Diameter In-segment After Stent Implantation

    Time frame: Post-procedure, Day 0

    Minimum lumen diameter in-segment after stent implantation assessed by Angiography

  13. Minimum Lumen Diameter In-stent After Stent Implantation

    Time frame: Post-procedure, Day 0

    Minimum lumen diameter in-stent after stent implantation assessed by Angiography

  14. Number of Participants With Dissection Type B or Greater

    Time frame: Post-CBA/NCBA before stent and after stent, Day 0

    Number of Participants with Dissection Type B or greater before and after stent implantation assessed by Angiography.

  15. Number of Participants With Perforation (Ellis Type ≥2) After Stent Implantation

    Time frame: Post-procedure, Day 0

    Number of Participants with perforation (Ellis type ≥2) after stent implantation assessed by Angiography. Perforation of a vessel

  16. Number of Participants With Side Branch Closure After Stent Implantation

    Time frame: Post-procedure, Day 0

    Number of Participants with side branch closure after stent implantation assessed by Angiography. Occlusion of a side branch

  17. Number of Participants With a Balloon Rupture

    Time frame: Post-Procedure, Day 0

    Device problem; Rupture of the cutting balloon or plain old balloon

  18. Number of Participants With Blade Detachment

    Time frame: Post-Procedure, Day 0

    Device problem; detachment of a blade from the cutting balloon

  19. Number of Participants With Difficulty in Withdrawing/Advancing the Device

    Time frame: Post-Procedure, Day 0

    Device problem; difficulty in moving the balloon within the vessel during the procedure

  20. Number of Participants Who Died of All-causes (Cardiac and Non-cardiac) After Percutaneous Coronary Intervention

    Time frame: 30 days

  21. Number of Participants Who Died of Cardiac Death After Percutaneous Coronary Intervention

    Time frame: 30 days

    Cardiac Death

  22. Number of Participants Who Died of Non-Cardiac Death After Percutaneous Coronary Intervention

    Time frame: 30 days

    Non-Cardiac Death

  23. Number of Participants With Myocardial Infarction, as Defined by the Society for Cardiovascular Angiography and Intervention (SCAI), After Percutaneous Coronary Intervention

    Time frame: 30 days

    The Society for Cardiovascular Angiography and Intervention (SCAI) defines clinically relevant MI after PCI as an elevation of cardiac biomarkers (CK-MB or troponin) above specified thresholds within 48 hours of the procedure, with or without new Q waves or LBBB on ECG. This definition aims to identify meaningful ischemic injury to the myocardium that is associated with adverse clinical outcomes.

  24. Percent of Participants With Myocardial Infarction, as Defined by 4th Universal Definition, After Percutaneous Coronary Intervention

    Time frame: 30 days

    Myocardial infarction is defined as heart muscle damage due to lack of blood flow, based on characteristic symptoms, ECG changes, and cardiac biomarker elevation, especially troponin. Elevated levels of cardiac biomarkers, especially troponin, along with ECG changes and cardiac symptoms, indicate myocardial infarction according to the universal definition.

  25. Number of Participants With Target Lesion Revascularization After Percutaneous Coronary Intervention

    Time frame: 30 days

    Revascularization

  26. Number of Participants With Target Vessel Revascularization After Percutaneous Coronary Intervention

    Time frame: 30 days

    Revascularization

  27. Number of Participants With Stent Thrombosis (Definite/Probable) After Percutaneous Coronary Intervention

    Time frame: 30 days

    Stent Thrombosis

  28. Number of Participants With Major Bleeding (BARC 3 or 5) After Percutaneous Coronary Intervention

    Time frame: 30 days

    Bleeding Academic Research Consortium (BARC) Type 3

    • Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding
    • Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents
    • Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision

    Type 5

    • Probable fatal bleeding
    • Definite fatal bleeding (overt or autopsy or imaging confirmation)

  29. Number of Participants With Vascular Complications After Percutaneous Coronary Intervention

    Time frame: 30 days

    Vascular complication

  30. Angina Status According to Canadian Cardiovascular Society (CSS) Classification

    Time frame: 270 days

    The Canadian Cardiovascular Society (CCS) grading scale is a classification system used to grade the severity of angina pectoris based on symptoms and their relationship to physical activity.

    Grade I: Ordinary physical activity like walking does not cause angina. Angina only occurs with strenuous, rapid, prolonged exertion during recreation or work.

    Grade II: Slight limitation of ordinary activity. Angina occurs when walking/climbing stairs rapidly, walking uphill, after meals, in cold/wind, under stress, or early morning. Angina occurs when walking more than 2 blocks or climbing more than 1 flight of stairs at a normal pace.

    Grade III: Marked limitation of ordinary activity. Angina occurs when walking 1-2 blocks or climbing 1 flight of stairs at a normal pace.

    Grade IV: Inability to carry out any physical activity without angina. Anginal symptoms may be present at rest.

    Higher grades indicate more limitations to activity due to angina.

Sponsors and collaborators

Lead sponsor

Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.

Other

Registry information

Acronym: ROTA-CUT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2021
Registry last updated
May 22, 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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