MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

{ "MagicTouch™ Sirolimus-Coated Balloon for Small Coronary Artery Lesions", "This study is testing a new device called the MagicTouch™ Sirolimus-Coated Balloon for treating blockages in small heart arteries. It compares this balloon to standard drug-eluting stents (DES). The goal is to see how safe and effective the MagicTouch™ balloon is for people with coronary artery disease, specifically in arteries that are 2.75 mm or smaller. You might be able to join if you are between 18 and 80 years old and need a procedure for stable angina, NSTEACS (a type of heart attack), or other heart-related chest pain. The study will measure how well the treatment works by looking at \"target lesion failure\" (TLF), which means if the treated area causes problems again, within 12 months. The study is currently recruiting about 1605 participants.", "design": "This is a randomized, single-blind study comparing the MagicTouch™ Sirolimus-Coated Balloon to drug-eluting stents, with approximately 1605 participants.", "commitments": "You would have a physical exam, lab tests, and an ECG before the procedure. You would also complete a questionnaire at baseline, 30 days, 6 months, and 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 12 months after the intervention to assess target lesion failure.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06271590

MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

Recruiting
NAAges 18–80InterventionalTreatment
Concept Medical Inc.
~1,605 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:Sirolimus Drug Coated BalloonDrug eluting stents (DES)

At a glance

Recruiting sites
5 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Target lesion failure (TLF)
Measured over within 12 months
Coronary Artery Disease
Native Coronary Artery Stenosis
Cardiovascular Diseases
24 sites across 15 states
New York5
Florida4
Georgia2
Ohio2
Arizona1
California1
Illinois1
Mississippi1

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  • Target lesion failure (TLF)within 12 months

    the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization