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NCT05908331 · ClinicalTrials.gov registry record · NA
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
A NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Concept Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 492
- Enrollment target
- 20
- Study locations
NCT05908331: Recruiting NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Concept Medical.
NCT05908331 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 492 participants, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05908331, a NA study of Cardiovascular Diseases and Coronary Artery Disease, is actively recruiting participants, sponsored by Concept Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 492 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
Primary Outcome
The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)
Conditions Studied
Interventions
- DEVICE Sirolimus Drug Coated Balloon
- DEVICE Plan balloon Angioplasty (POBA)
Study Locations (20)
Florida
- Cheek-Powell Heart and Vascular Pavilion - Clearwater
- Clearwater Cardiovascular and Interventional Consultants - Clearwater
- The Cardiac & Vascular Institute Research Foundation - Gainesville
- Tampa General Hospital / University of South Florida - Tampa
New York
- VA New York Harbor Healthcare System - New York
- NYU Langone Health - New York
- Columbia University Medical Center/NYPH - New York
- Montefiore Medical Center - Moses Division - The Bronx
Minnesota
- Metropolitan Heart and Vascular Institute - Coon Rapids
- Minneapolis Heart Institute Foundation - Minneapolis
Mississippi
- Cardiology Associates Research, LLC - Tupelo
- Cardiology Associates Research, LLC - Tupelo
Alabama
- Cardiology, PC - Princeton Baptist Medical Center - Birmingham
Arizona
- Dignity Health - Mercy Gilbert Medical Center - Gilbert
California
- Cedars - Sinai Medical Center - Los Angeles
Connecticut
- Yale University / Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2028-07 |
| Phase | NA |
What NCT05908331 shows while recruiting
NCT05908331 is an interventional study that assigns participants to a tested intervention. The registered 492 participants enrollment target is mid-sized for trials with a published cap, below the 26,973-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (98% 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.
NCT05908331 names 20 study sites across 12 states, led by Florida, New York, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05908331 about?
NCT05908331 is a clinical study titled "MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions". A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions unde...
What is the current status of trial NCT05908331?
This trial is currently recruiting. It is a NA study. The enrollment target is 492 participants. The study started on 2024-04-16. Estimated completion is 2028-07.
What conditions does trial NCT05908331 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, In-Stent Restenosis.
What interventions are being tested in trial NCT05908331?
The interventions under investigation include: Sirolimus Drug Coated Balloon (DEVICE), Plan balloon Angioplasty (POBA) (DEVICE).
Who is sponsoring clinical trial NCT05908331?
This trial is sponsored by Concept Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05908331 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT05908331's enrollment target sits among peer trials
492 100th of 300 higher than 201 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.
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