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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 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 weeks
Treatment ~ Varies
Follow Up ~270 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
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
+27 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

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
~20 spots leftby Jun 2025
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