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MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

NCT05908331 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2025-02-25

No results posted yet for this 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).

Conditions

Interventions

DEVICE

Sirolimus Drug Coated Balloon

Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.

DEVICE

Plan balloon Angioplasty (POBA)

Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis

Sponsors & Collaborators

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Concept Medical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2025-09-30
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908331 on ClinicalTrials.gov