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

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

Status

Completed

Conditions

Coronary Artery Disease

Atherosclerosis

Treatments

Device: cutting balloon

Procedure: rotational atherectomy

Device: plain old balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT04865588

GCO 21-0532

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: