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

NCT ID: NCT04865588

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2023-12-12

Brief 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 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.

Detailed 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.

Conditions

Coronary Artery Disease; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rotational atherectomy + cutting balloon

angioplasty with rotational atherectomy followed by cutting balloon

Group Type: ACTIVE_COMPARATOR

rotational atherectomy

Intervention Type: PROCEDURE

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

cutting balloon

Intervention Type: DEVICE

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

rotational atherectomy + plain old balloon

angioplasty with rotational atherectomy followed by plain old balloon

Group Type: ACTIVE_COMPARATOR

rotational atherectomy

Intervention Type: PROCEDURE

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

plain old balloon

Intervention Type: DEVICE

current standard treatment of stent placement

Interventions

rotational atherectomy

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

Intervention Type: PROCEDURE

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

Intervention Type: DEVICE

plain old balloon

current standard treatment of stent placement

Intervention Type: DEVICE

Eligibility 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

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

Professor of Medicine/Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samin K Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

The Icahn School of Medicine at Mount Sinai

New York, New York, United States

Saint Francis Hospital and Heart Center

Roslyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 21-0532

Identifier Type: -

Identifier Source: org_study_id