240
Participants
Start Date
November 13, 2020
Primary Completion Date
June 3, 2025
Study Completion Date
February 28, 2029
IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort
For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
For treatment of stenosis in the AV circuit
The Mount Sinai Hospital, New York
Staten Island University Hospital, Staten Island
Albany Medical College, Albany
Lancaster General Hospital, Lancaster
Medstar Washington Hospital, Washington D.C.
University of Virginia Medical Center, Charlottesville
FirstHealth of the Carolinas, Pinehurst
MUSC Health Dialysis Access Institute, Orangeburg
Spartanburg Regional Medical Center, Spartanburg
Coastal Vascular and Interventional, Pensacola
NCH Healthcare System, Naples
University of Michigan Health System - University Hospital, Ann Arbor
University of Iowa, Iowa City
University of Wisconsin-Madison - Meriter Hospital, Madison
Mayo Clinic, Rochester
Cedars-Sinai Heart Institute, Los Angeles
Stanford University Medical Center, Stanford
Oregon Health & Science University Hospital, Portland
Yale New Haven Hospital, New Haven
Holy Name Medical Center, Teaneck
Lead Sponsor
Medtronic
INDUSTRY