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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• Subject is at least 18 years old

• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment

• Patient with an indication for PCI due to suspected in-stent restenosis

• Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:

⁃ Angiographic Inclusion Criteria:

• In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)

• Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms

• Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting

• Target lesion in a native coronary artery

• Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion

• Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm

• Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon

• One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)

• Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization

Locations
United States
Alabama
Cardiology, PC - Princeton Baptist Medical Center
RECRUITING
Birmingham
Arizona
Dignity Health - Mercy Gilbert Medical Center
RECRUITING
Gilbert
California
Cedars - Sinai Medical Center
RECRUITING
Los Angeles
Connecticut
Yale University / Yale New Haven Hospital
RECRUITING
New Haven
Florida
Cheek-Powell Heart and Vascular Pavilion
RECRUITING
Clearwater
Clearwater Cardiovascular and Interventional Consultants
RECRUITING
Clearwater
The Cardiac & Vascular Institute Research Foundation
RECRUITING
Gainesville
Tampa General Hospital / University of South Florida
RECRUITING
Tampa
Georgia
Atlanta VA Medical Center
RECRUITING
Decatur
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Minnesota
Metropolitan Heart and Vascular Institute
NOT_YET_RECRUITING
Coon Rapids
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Mississippi
Cardiology Associates Research, LLC
RECRUITING
Tupelo
Cardiology Associates Research, LLC
RECRUITING
Tupelo
North Carolina
NC Heart and Vascular Research, LLC
NOT_YET_RECRUITING
Raleigh
New Jersey
AtlantiCare Regional Medical Center
RECRUITING
Pomona
New York
Columbia University Medical Center/NYPH
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
VA New York Harbor Healthcare System
RECRUITING
New York
Montefiore Medical Center - Moses Division
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
Oklahoma University Health (OU Health)
RECRUITING
Oklahoma City
Oregon
Providence St. Vincent Medical Center
RECRUITING
Portland
South Carolina
Prisma Health
RECRUITING
Greenville
Tennessee
Centennial Medical Center
RECRUITING
Nashville
Texas
Baylor Scott and White Heart and Vascular Hospital
RECRUITING
Dallas
Baylor Scott & White - The Heart Hospital - Plano
RECRUITING
Plano
West Virginia
West Virginia University and Vascular Institute
RECRUITING
Morgantown
Contact Information
Primary
Dario Gattuso
dario@conceptmedical.com
+393292467132
Backup
Farhana Siddique
farhana@conceptmedical.com
+919725495366
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2028-07
Participants
Target number of participants: 492
Treatments
Experimental: MagicTouch Sirolimus-Coated Balloon
Magic TouchTM is a Sirolimus Coated Balloon catheter intended to be used in coronary applications, treats the atherosclerosis of the coronary arteries by eluting the immunosuppressant agent Sirolimus without leaving behind a metallic scaffold.
Active_comparator: POBA
plain old balloon angioplasty
Sponsors
Leads: Concept Medical Inc.
Collaborators: Cardiovascular Research Foundation, New York

This content was sourced from clinicaltrials.gov