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RECRUITING NA

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

NCT06271590 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Concept Medical

34 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,605 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Concept Medical, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06271590 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06271590?

The interventions under investigation include: Sirolimus Drug Coated Balloon (DEVICE), Drug eluting stents (DES) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06271590?

This trial is sponsored by Concept Medical, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial