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NCT06271590 · ClinicalTrials.gov registry record · NA

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

A NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Concept Medical.

Recruiting
Registry status
NA
Development phase
1,605
Enrollment target
20
Study locations

NCT06271590: Recruiting NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Concept Medical.

NCT06271590 is a NA study of Cardiovascular Diseases and Coronary Artery Disease that is actively recruiting participants, run by Concept Medical. The registered enrollment target is 1,605 participants, below the 26,969-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06271590, a NA study of Cardiovascular Diseases and Coronary Artery Disease, is actively recruiting participants, sponsored by Concept Medical.

RECRUITING
Registry status
NA
Development phase
1,605 participants
Enrollment target
20
Study locations

Study Summary

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

Primary Outcome

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

Interventions

  • DEVICE Sirolimus Drug Coated Balloon
  • DEVICE Drug eluting stents (DES)

Study Locations (20)

New York

  • University Hospitals, Cleveland Medical Center - Brooklyn
  • North Shore University Hospital - Northwell - Manhasset
  • Icahn School of Medicine at Mount Sinai/ Mount Sinai Hospital - New York
  • Columbia University/NYP - New York
  • Montefiore Medical Center - The Bronx

Florida

  • Clearwater Cardiovascular and Interventional Consultants - Clearwater
  • University of Florida Health Sciences Center-Jacksonville - Jacksonville
  • Tallahassee Research Institute - Tallahassee
  • Tampa General Hospital / University of South Florida - Tampa

Georgia

  • Emory University Hospital /Emory School of Medice - Atlanta
  • Atlanta VA Medical Center - Decatur

Ohio

  • University Hospitals, Cleveland Medical Center - Cleveland
  • Cleveland Clinic - Cleveland

Arizona

  • Dignity Health - Mercy Gilbert Medical Center - Gilbert

California

  • Cedars-Sinai Medical Center - Los Angeles

Illinois

  • Loyola University Medical Center - Maywood

Mississippi

  • North Mississippi Medical Center - Tupelo

Trial Details

FieldValue
Enrollment Target 1,605 participants
Start Date 2025-05-20
Est. Completion 2031-11
Phase NA
Concept Medical

3 total trials

What NCT06271590 shows while recruiting

NCT06271590 is an interventional study that assigns participants to a tested intervention. Its 1,605 participants enrollment target places it among the larger protocols in the corpus, below the 26,969-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (94% lower).

The record links to 3 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Sirolimus Drug Coated Balloon is the first listed.

NCT06271590 names 20 study sites across 11 states, led by New York, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06271590 about?

NCT06271590 is a clinical study titled "MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels". This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated bal...

What is the current status of trial NCT06271590?

This trial is currently recruiting. It is a NA study. The enrollment target is 1,605 participants. The study started on 2025-05-20. Estimated completion is 2031-11.

What conditions does trial NCT06271590 study?

This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, Native Coronary Artery Stenosis.

What interventions are being tested in trial NCT06271590?

The interventions under investigation include: Sirolimus Drug Coated Balloon (DEVICE), Drug eluting stents (DES) (DEVICE).

Who is sponsoring clinical trial NCT06271590?

This trial is sponsored by Concept Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06271590 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cardiovascular Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06271590's enrollment target sits among peer trials

1,605 43rd of 300 higher than 258 of 300 other Cardiovascular Diseases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06271590, the US trial registry maintained by the National Library of Medicine. NCT06271590 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.