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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Concept Medical Inc.
Study ID
NCT05908331
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases
  • Coronary Artery Disease
  • In-Stent Restenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Sirolimus Drug Coated Balloon — DEVICE
    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.
  • Plan balloon Angioplasty (POBA) — DEVICE
    Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis

Study Details

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).

Key Dates

Start date
Apr 16, 2024
Status verified
Feb 2025
Primary completion
Sep 30, 2025
Completion
Jul 31, 2028

Study Design

Enrollment
492 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

TLF (Target Lesion Failure) [ Time Frame: 12 months ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Cardiology, PC - Princeton Baptist Medical CenterBirminghamAlabama35211-
Dignity Health - Mercy Gilbert Medical CenterGilbertArizona85297
Jennifer Vermillion
[email protected]
480-728-9973
Nabil Dib (PRINCIPAL_INVESTIGATOR)
Cedars - Sinai Medical CenterLos AngelesCalifornia90048
Mitch Gheorghiu
[email protected]
310 4236152
Raj Makkar (PRINCIPAL_INVESTIGATOR)
Yale University / Yale New Haven HospitalNew HavenConnecticut06519-
Cheek-Powell Heart and Vascular PavilionClearwaterFlorida33756
Bernardo Stein
Bernardo Stein (PRINCIPAL_INVESTIGATOR)
Clearwater Cardiovascular and Interventional ConsultantsClearwaterFlorida33756
Jaclyn Rutledge
[email protected]
1-727-467-9393
Bernardo Stein (PRINCIPAL_INVESTIGATOR)
The Cardiac & Vascular Institute Research FoundationGainesvilleFlorida32605
Marti Roberson
[email protected]
(352)244-0208
Matheen Khuddus (PRINCIPAL_INVESTIGATOR)
Tampa General Hospital / University of South FloridaTampaFlorida33606
Hiram Bezerra
[email protected]
8138448287
Hiram Bezerra (PRINCIPAL_INVESTIGATOR)
Atlanta VA Medical CenterDecaturGeorgia30033
Savitha Shivaraj
[email protected]
1 4042638204
Rajesh Sachdeva (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jenifer M Kaufman
[email protected]
01-617-632-8956
Robert Yeh (PRINCIPAL_INVESTIGATOR)
Metropolitan Heart and Vascular InstituteCoon RapidsMinnesota55433
Derek Vang
[email protected]
763-236-9347
Matthew G Whitbeck (PRINCIPAL_INVESTIGATOR)
Randall P Stark (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
Tamara O Black
[email protected]
612-863-6226
Yader Sandoval (PRINCIPAL_INVESTIGATOR)
Cardiology Associates Research, LLCTupeloMississippi38801
Barry Bertolet
Barry Bertolet (PRINCIPAL_INVESTIGATOR)
Cardiology Associates Research, LLCTupeloMississippi38801
Yvonne Ray
[email protected]
662-377-5447
Barry Bertolet (PRINCIPAL_INVESTIGATOR)
AtlantiCare Regional Medical CenterPomonaNew Jersey08240
Jackie White
[email protected]
609-404-7654
Said Ashraf (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/NYPHNew YorkNew York10032
Ajay Kirtane
Jeffrey Moses (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Natalie S. Massenburg
Razzouk Louai (PRINCIPAL_INVESTIGATOR)
VA New York Harbor Healthcare SystemNew YorkNew York10010
Leandro Maranan
[email protected]
347-228-6951
Nathaniel Smilowitz (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center - Moses DivisionThe BronxNew York10467
Azeem Latib
Judah Rauch (PRINCIPAL_INVESTIGATOR)
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607
James Pierre-Loius
[email protected]
919-784-7695
James P Zidar (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Susan Hejl
[email protected]
216-445-6817
Amar Krishnaswamy (PRINCIPAL_INVESTIGATOR)
Oklahoma University Health (OU Health)Oklahoma CityOklahoma73104
Michael Stout
[email protected]
14502719060
Mohit Pahuja (PRINCIPAL_INVESTIGATOR)
Providence St. Vincent Medical CenterPortlandOregon97225
Bethany Wilson
[email protected]
5032167275
Jason Wollmuth (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29605-5601
Lindsey Bentley
[email protected]
864-455-7377
Jesse Jorgensen (PRINCIPAL_INVESTIGATOR)
Centennial Medical CenterNashvilleTennessee37203
Drew Quillen
[email protected]
6154171035
Brian Jefferson (PRINCIPAL_INVESTIGATOR)
Baylor Scott and White Heart and Vascular HospitalDallasTexas75226
Rebecca Baker
[email protected]
214-820-9903
Robert Stoler (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White - The Heart Hospital - PlanoPlanoTexas75093
Osniel Gonzalez Ramos
[email protected]
469-814-4862
Karim Al-Azizi (PRINCIPAL_INVESTIGATOR)
West Virginia University and Vascular InstituteMorgantownWest Virginia26506
Josh Bomabrd
3042851980
Ramesh Daggubati (PRINCIPAL_INVESTIGATOR)

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Cardiology, PC - Princeton Baptist Medical Center· Birmingham, ALDignity Health - Mercy Gilbert Medical Center· Gilbert, AZCedars - Sinai Medical Center· Los Angeles, CAYale University / Yale New Haven Hospital· New Haven, CTCheek-Powell Heart and Vascular Pavilion· Clearwater, FLClearwater Cardiovascular and Interventional Consultants· Clearwater, FL

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