368
Participants
Start Date
January 16, 2025
Primary Completion Date
December 1, 2026
Study Completion Date
February 1, 2031
MagicTouch PTA Sirolimus drug coated balloon
All patients must first be treated with pre dilatation with a standard balloon angioplasty using any standard balloon catheters at the discretion of the operator. Magic Touch PTA Sirolimus coated balloon catheter is an adjunct treatment that should be used in combination with standard balloon angioplasty. Following successful crossing of wire across the lesion and plain balloon angioplasty of arterial lesion with successful lesion preparation with residual lesion \<30%, subjects will be randomized to receive study device balloon. If patients are assigned to MagicTouch PTA Sirolimus DCB, the Angioplasty of lower limb will be performed with this device in addition to standard balloon angioplasty.
Placebo balloon angioplasty
For participants randomized to a Placebo balloon angioplasty group, a Placebo balloon angioplasty in addition to standard balloon angioplasty will be performed.
RECRUITING
The Mount Sinai Hospital, New York
RECRUITING
Columbia University Irving Medical center/NYPH, New York
RECRUITING
New York Presbyterian - Weill Cornell Medical Center Vascular & Endovascular Surgery, New York
RECRUITING
Westchester Medical Center, Valhalla
RECRUITING
Northwell Health Long Island Jewish Medical Center, Lake Success
RECRUITING
Lankenau Institute for Medical Research Bryn Mawr Hospital, Bryn Mawr
RECRUITING
University of Pennsylvania - Penn Heart and Vascular Center, Philadelphia
RECRUITING
Medical University of South Carolina(MUSC) Health Ashley River Tower, Charleston
RECRUITING
Baptist Hospital of Miami, Miami
RECRUITING
University of South Florida, Tampa
RECRUITING
Clearwater Cardiovascular Consultants, Clearwater
RECRUITING
University Hospitals Cleveland Medical Center, Cleveland
RECRUITING
The Christ Hospital Network Outpatient Center, Cincinnati
RECRUITING
Unity Point Health Des Moines, Des Moines
RECRUITING
Vascular Institute of the Midwest, Davenport
RECRUITING
The Heart Hospital Baylor Plano, Plano
RECRUITING
Baylor Research Institute, Dallas
RECRUITING
Ascension Seton Medical Center Austin, Austin
RECRUITING
Honor Health Research & Innovation Institute, Scottsdale
NOT_YET_RECRUITING
University of California Los Angeles, Los Angeles
RECRUITING
University of Washington Seattle, Seattle
RECRUITING
Deborah Heart and Lung Center, Browns Mills
RECRUITING
Virtua Healthcare - Virtua Our Lady of Lourdes, Marlton
Lead Sponsor
Concept Medical Inc.
INDUSTRY