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

NCT04865588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Samin K Sharma, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-04-04
Completion
2023-12-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865588 on ClinicalTrials.gov