Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions (ROTA-CUT)

  • STATUS
    Recruiting
  • End date
    Dec 10, 2023
  • participants needed
    60
  • sponsor
    Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Updated on 10 August 2022
angiography
percutaneous coronary intervention

Summary

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 artherectomy 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.

Description

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 artherectomy followed by plain old balloon (ROTA + POBA) in a 1:1 ratio.

The clinical investigation will be conducted at 2 centers in the US. 30 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.

Details
Condition Coronary Artery Disease, Atherosclerosis
Treatment Rotational Atherectomy, cutting balloon, plain old balloon
Clinical Study IdentifierNCT04865588
SponsorSamin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

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)
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