306
Participants
Start Date
February 22, 2017
Primary Completion Date
May 12, 2020
Study Completion Date
June 2, 2022
Shockwave Lithoplasty® Peripheral Lithoplasty System
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
Medtronic IN.PACT (DCB)
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
Auckland City Hospital, Auckland
Gefäßsambulanz, Vienna
Medizinische Universitaet Graz, Graz
Mount Sinai West, New York
Icahn School of Medicine at Mount Sinai, New York
Columbia University Medical Center/New York Presbyterian Hospital, New York
Sankt Gertrauden-Krankenhaus, Berlin
PinnacleHealth Harrisburg Hospital, Harrisburg
Bryn Mawr Hospital, Bryn Mawr
Lankenau Institute for Medical Research, Wynnewood
Einstein Medical Center Philadelphia, Philadelphia
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center, Washington D.C.
Klinik für Gefäßmedizin, Hamburg
Charleston Area Medical Center, Charleston
NC Heart & Vascular Research, Raleigh
WakeMed Health & Hospitals, Raleigh
Piedmont Heart Institute, Atlanta
Northeast Georgia Medical Center, Gainesville
Tallahassee Research Institute, Inc., Tallahassee
Wellmont CVA Heart Institute, Kingsport
Tennova Healthcare - Turkey Creek Medical Center, Knoxville
Baptist Medical Center, Memphis
North Mississippi Medical Center, Tupelo
Ohio Health Research Institute, Columbus
Evangelisches Krankenhaus Mühlheim an der Ruhr, Mülheim
Ascension / St. John Providence, Southfield
St. Franziskus Hospital, Münster
St. Joseph Mercy Oakland, Pontiac
Midwest Cardiovascular Research Foundation, Davenport
Leiter Sektion Angiologie, Bonn
Katholisches Klinikum Mainz, Mainz
Karolinen-Hospital, Arnsberg
Alexian Brothers Medical Center, Elk Grove Village
Advocate Health and Hospitals Corporation, Naperville
Prairie Education & Research Cooperative, Springfield
St. Luke's East Hospital, Lee's Summit
Saint Luke's Cardiovascular Consultants, Kansas City
Arkansas Heart Hospital, Little Rock
St. John Clinic, Bartlesville
Medizinische Klinik II, Bruchsal
Baylor College of Medicine, Houston
St. David's Heart and Vascular dba Austin Heart, Austin
Universitäts-Herzzentrum Freiburg & Bad Krozingen, Bad Krozingen
Rocky Mountain Regional VA Medical Center, Aurora
UCHealth Northern Colorado, Loveland
RoMed Klinikum Rosenheim, Rosenheim
Stanford Hospital, Palo Alto
Providence Portland Medical Center, Portland
Providence Heart & Vascular Institute, Portland
Yale New Haven Hospital, New Haven
Steward St. Elizabeth's Medical Center, Brighton
Deborah Heart and Lung Center, Browns Mills
The Miriam Hospital, Providence
Universitätsklinikum Leipzig AoR Leipzig, Leipzig
Shockwave Medical, Inc.
INDUSTRY