Last updated on June 2018

Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)


Brief description of study

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.

In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.

The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.

A maximum of 500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.

Detailed Study Description

Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.

Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab.

Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 16 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.

Clinical Study Identifier: NCT02923193

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Venkatesh Ramaiah, MD

Abrazo Arizona Heart Hospital
Phoenix, AZ United States
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Michael Dake, MD

Stanford Hospital
Palo Alto, CA United States
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William Miller, MD

UCHealth Northern Colorado
Loveland, CO United States
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Carlos Mena, MD

Yale New Haven Hospital
New Haven, CT United States
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William Dixon, MD

Tallahassee Research Institute, Inc.
Tallahassee, FL United States
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Jeff Marshall, MD

Northeast Georgia Medical Center
Gainesville, GA United States
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Mark Goodwin, MD

Advocate Health and Hospitals Corporation
Oakbrook Terrace, IL United States
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Nilesh J. Goswami, M.D.

Prairie Education & Research Cooperative
Springfield, IL United States
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Nicholas Shammas, MD

Midwest Cardiovascular Research Foundation
Davenport, IA United States
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Lawrence Garcia, MD

Steward St. Elizabeth's Medical Center
Brighton, ME United States
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Pojai Phattanagosai

Ascension / St. John Hospital and Medical Center
Detroit, MI United States
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Patrick Alexander, MD

Ascension / St. John Providence
Southfield, MI United States
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Barry Bertolet, MD

North Mississippi Medical Center
Tupelo, MS United States
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Pojai Phattanagosai

Saint Louis University
Saint Louis, MO United States
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Steve Henao, MD

New Mexico Heart Institute
Albuquerque, NM United States
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Prakash Krishnan, MD

Icahn School of Medicine at Mount Sinai
New York, NY United States
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Sahil Parikh, MD

Columbia University Medical Center/New York Presbyterian Hospital
New York, NY United States
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George Adams, MD

NC Heart & Vascular Research
Raleigh, NC United States
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Siddhartha Rao, MD

WakeMed Heart Center
Raleigh, NC United States
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John A Phillips, MD

Ohio Health Research Institute
Columbus, OH United States
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William Bachinsky, MD

PinnacleHealth Harrisburg Hospital
Harrisburg, PA United States
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William Bachinsky, MD

Pinnacle Health Cardiovascular Institute
Wormleysburg, PA United States
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Sarang Mangalmurti, MD

Lankenau Heart Center
Wynnewood, PA United States
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Peter Soukas, MD

The Miriam Hospital
Providence, RI United States
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Christopher Metzger, MD

Wellmont CVA Heart Institute
Kingsport, TN United States
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Malcolm Foster III, MD, FACC

Tennova Healthcare - Turkey Creek Medical Center
Knoxville, TN United States
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Roger Gammon, MD

St. David's Heart and Vascular dba Austin Heart
Austin, TX United States
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Marianne Brodmann, MD

Medizinische Universitaet Graz
Graz, Austria
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Martin Werner, MD

Hanusch Krankenhaus
Vienna, Austria
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Michael Lichtenberg, MD

Karolinen-Hospital
Arnsberg, Germany
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Thomas Zeller, MD

Universit ts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen, Germany
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Ralf Langhoff, MD

Sankt Gertrauden-Krankenhaus
Berlin, Germany
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Tanja Streuber

International Center for Cardiovascular Interventions (ICCI)
Bonn, Germany
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Tanja Streuber

Leiter Sektion Angiologie
Bonn, Germany
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Martin Andrassy, MD

Medizinische Klinik II
Bruchsal, Germany
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Hans Krankenberg, MD

Klinik f r Gef medizin
Hamburg, Germany
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Dierk Scheinert, MD

Universit tsklinikum Leipzig AoR Leipzig
Leipzig, Germany
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John O Balzer, MD

Katholisches Klinikum Mainz
Mainz, Germany
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Arne Schwindt, MD

St. Franziskus Hospital
Munster, Germany
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Gunnar Tepe, MD

RoMed Klinikum Rosenheim
Rosenheim, Germany
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Andrew Holden, MD

Auckland City Hospital
Auckland, New Zealand
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Ian Cawich, MD

Arkansas Heart Hospital
Little Rock, AR United States
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Ehrin Armstrong, MD

Denver VA Medical Center
Denver, CO United States
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Tareq Massimi, MD

MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
Washington, WA United States
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Jack Chamberlin, MD

Alexian Brothers Medical Center
Elk Grove Village, IL United States
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Kirit Patel, MD

St. Joseph Mercy Oakland
Pontiac, MI United States
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Steven Laster, MD

Saint Luke's Cardiovascular
Kansas City, MO United States
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Vince Varghese, MD

Deborah Heart and Lung
Browns Mills, NJ United States
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James McKinsey, MD

Mount Sinai West
New York, NY United States
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Sean Janzer, MD

Einstein Medical Center Philadelphia
Philadelphia, PA United States
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Miguel Montero, MD

Baylor College of Medicine
Houston, TX United States
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Claus Nolte-Ernsting, MD

Evangelisches Krankenhaus M hlheim an der Ruhr
Mülheim, Germany
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