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Procedure

Rotational Atherectomy + Cutting Balloon for Coronary Artery Disease and Atherosclerosis (ROTA-CUT Trial)

N/A

Waitlist Available

Led By Samin K Sharma, MD

Research Sponsored by Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 270 days

Awards & highlights

ROTA-CUT Trial Summary

This trial will test if using a cutting balloon in addition to rotational atherectomy will improve outcomes for treating blocked arteries due to calcification.

Eligible Conditions

Atherosclerosis
Coronary Artery Disease

ROTA-CUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 270 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 270 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 270 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Minimum Stent Area after Percutaneous Coronary Intervention assessed by intravascular ultrasound

Secondary outcome measures

Acute lumen gain in segment after stent implantation assessed by Angiography

Acute lumen gain in stent after stent implantation assessed by Angiography

Angina status according to Canadian Cardiovascular Society (CSS) classification

+28 more

ROTA-CUT Trial Design

2Treatment groups

Active Control

Group I: rotational atherectomy + cutting balloonActive Control2 Interventions

angioplasty with rotational atherectomy followed by cutting balloon

Group II: rotational atherectomy + plain old balloonActive Control2 Interventions

angioplasty with rotational atherectomy followed by plain old balloon

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

Samin K Sharma, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

350 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for the current trial open to new participants?

"This research study, initially posted on May 13th 2022 is actively seeking participants. According to information present on clinicaltrials.gov the trial was recently updated on July 28th of this same year."

Answered by AI

What is the current participant quota for this trial?

"Affirmative. The clinicaltrials.gov records affirm that this scientific research, which was originally posted on May 13th 2022, is currently attempting to recruit participants. Two medical centres need to sign up 60 patients for the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Samin Sharma, M.D., F.A.C.C., M.S.C.A.I. 2022. "Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04865588.