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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,605 participants |
| Start Date | 2025-05-20 |
| Est. Completion | 2031-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06271590
The ClinicalTrials.gov registry entry for NCT06271590 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,605 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,969-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (94% lower). The listed sponsor is Concept Medical, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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