NCT04865588

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	rotational atherectomy	angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
DEVICE	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
DEVICE	plain old balloon	current standard treatment of stent placement

Timeline

• Start date: 2022-05-13
• Primary completion: 2023-04-04
• Completion: 2023-12-12
• First posted: 2021-04-29
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study