Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries

Status: Completed
Location: See all (54) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 1000 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subject is able and willing to comply with all assessments in the study.

• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.

• Age of subject is greater than or equal to 18.

• Rutherford Clinical Category 2, 3, or 4 of the target limb.

• Estimated life expectancy >1 year.

• Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.

• Subject is intended to undergo treatment with Lithoplasty followed by DCB, or DCB with standard balloon pre-dilatation.

• Angiographic Inclusion Criteria

• Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).

• Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.

• Target lesion is ≥70% stenosis by investigator via visual estimate.

• Target lesion length is ≤180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.

• Chronic total occlusion, lesion length is ≤100mm of the total ≤180 mm target lesion.

• Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.

• Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

• Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.

• Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.

• Age of subject is > 18.

• Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.

• Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Locations
United States
Arkansas
Arkansas Heart Hospital
Little Rock
California
Stanford Hospital
Palo Alto
Colorado
Rocky Mountain Regional VA Medical Center
Aurora
UCHealth Northern Colorado
Loveland
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
Washington
Florida
Tallahassee Research Institute, Inc.
Tallahassee
Georgia
Piedmont Heart Institute
Atlanta
Northeast Georgia Medical Center
Gainesville
Iowa
Midwest Cardiovascular Research Foundation
Davenport
Illinois
Alexian Brothers Medical Center
Elk Grove Village
Advocate Health and Hospitals Corporation
Naperville
Prairie Education & Research Cooperative
Springfield
Maine
Steward St. Elizabeth's Medical Center
Brighton
Michigan
St. Joseph Mercy Oakland
Pontiac
Ascension / St. John Providence
Southfield
Missouri
Saint Luke's Cardiovascular Consultants
Kansas City
St. Luke's East Hospital
Lee's Summit
Mississippi
North Mississippi Medical Center
Tupelo
North Carolina
NC Heart & Vascular Research
Raleigh
WakeMed Health & Hospitals
Raleigh
New Jersey
Deborah Heart and Lung Center
Browns Mills
New York
Columbia University Medical Center/New York Presbyterian Hospital
New York
Icahn School of Medicine at Mount Sinai
New York
Mount Sinai West
New York
Ohio
Ohio Health Research Institute
Columbus
Oklahoma
St. John Clinic
Bartlesville
Oregon
Providence Heart & Vascular Institute
Portland
Providence Portland Medical Center
Portland
Pennsylvania
Bryn Mawr Hospital
Bryn Mawr
PinnacleHealth Harrisburg Hospital
Harrisburg
Einstein Medical Center Philadelphia
Philadelphia
Lankenau Institute for Medical Research
Wynnewood
Rhode Island
The Miriam Hospital
Providence
Tennessee
Wellmont CVA Heart Institute
Kingsport
Tennova Healthcare - Turkey Creek Medical Center
Knoxville
Baptist Medical Center
Memphis
Texas
St. David's Heart and Vascular dba Austin Heart
Austin
Baylor College of Medicine
Houston
West Virginia
Charleston Area Medical Center
Charleston
Other Locations
Austria
Medizinische Universitaet Graz
Graz
Gefäßsambulanz
Vienna
Germany
Karolinen-Hospital
Arnsberg
Universitäts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen
Sankt Gertrauden-Krankenhaus
Berlin
Leiter Sektion Angiologie
Bonn
Medizinische Klinik II
Bruchsal
Klinik für Gefäßmedizin
Hamburg
Universitätsklinikum Leipzig AoR Leipzig
Leipzig
Katholisches Klinikum Mainz
Mainz
Evangelisches Krankenhaus Mühlheim an der Ruhr
Mülheim
St. Franziskus Hospital
Munster
RoMed Klinikum Rosenheim
Rosenheim
New Zealand
Auckland City Hospital
Auckland
Time Frame
Start Date: February 22, 2017
Completion Date: June 2, 2022
Participants
Target number of participants: 306
Treatments
Experimental: Lithoplasty System followed by DCB
Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty
Active Comparator: Medtronic IN.PACT (DCB)
Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease.
Authors
Stahlhoff, Nickling, Schulz, Nancy Rose, Stehr, Joanna Brand, Willaim Gray, Vince Varghese, Ron Dalman, Mecklenbeck, E. John Harris, Papaioannou, Exler, Bekker, Renaldo Myrselai, Erica Elliot, Donas Konstantinos, John O Balzer, Matt Selmon, Pratik Parikh, Ankit Patel, Nicholas Morrissey, Pratik Desai, Joseph Stinson, Joan Hughart, Gabor Matos, Jayer Chung, Robert Attaran, Martyn Knowles, Barbara Solnek, Antonis Pratsos, Siddhartha Rao, Glen Henry, Thomas Noel, Shawna Duske, Anderson Mehrle, Venita Chandra, Aravinda Nanjundappa, Steven Laster, Brandon Jones, Richard Wilkerson, Francis Day, Anand Ramanathan, Lawrence Garcia, Atif Baqai, Vishal Kapur, Firas Barrow, Prashant Kaul, David Chang, Neil Strickman, Joel Schneider, Omar Hyder, Phil Green, Nicholas Shammas, Adam Salisbury, John A Phillips, Sourabh Mukherjee, Venkatesh Ramaiah, Sahil Parikh, David Loran, Ayman Jamal, Ethan Korngold, James Zidar, Charles Cannan, Anay Pradhan, Paul Grunenwald, Ajay Kirtane, Rajesh Malik, Mark Goodwin, Dorian DeFreitas, Ravi Mehta, Jason Lindsey, Andrew Klein, Mark Aziz, John Katopodis, Alan Moak, Andrew Yen, Tareq Massimi, Saba Khan, William A Gray, Morgan Johnson, William Miller, Donald Jacobs, Prakash Krishnan, Sean Janzer, Mitchell Silver, Steven Abramowitz, George Adams, Robert Fenning, Jon George, Mollie Bechtelheimer, Costin Ionescu, Cleon Hubbard, Brant Ullery, Sarang Mangalmurti, David Safley, Chad Laurich, Zvonimir Krajcer, Matthew Bunte, Edward Woo, Mark Leimbach, Jeffrey Goldstein, William Dixon, Danielle Bajakian, Miguel Montero, William Bachinsky, Jason Wollmuth, Liliana Nanez, Alejandro Perez, Ehrin Armstrong, James McKinsey, Trent Proffitt, Richard Kovach, Charles Botti, Vijay Raja, Michael Jolly, Peter Soukas, Andre Paixao, Kintur Sanghvi, Michael Dake, Mohit Pasi, Nilesh J. Goswami, Brian Go, Patrick Alexander, Aditi Madabhushi, Thomas Carlson, Jack Chamberlin, Ian Cawich, David Kandzari, Mukesh Sharma, Robert Mendes, Gary Ansel, Karthik Gujja, Allison Dupont, Jason Lee, Andrew Kurklinsky, Ravish Sachar, Nelson Bernardo, Albeir Mousa, Shafiq Mamdani, Sasanka Jayasuriya, Malcolm Foster III, Andrei Pop, Anthony Pucillo, Mark Picone, Frank Zidar, Barry Bertolet, Jason Kim, Mahesh Raju, Philip Dattilo, Virendra Patel, Roger Gammon, Kirit Patel, Arthur Topoulos, Joseph Mills, Andrew Unzeitig, Franka Borger, Peter Pfaffinger, Stephen Miller, Claire A Watkins, Andrea Behne, Claus Nolte-Ernsting, Ulrich Beschorner, Michael Lichtenberg, Alea Nazary, Nikos Werner, Krista Schöllhorn, Arne Schwindt, Ralf Langhoff, Dierk Scheinert, Anna Koll, Manuela Matschuck, Hans Krankenberg, Mark Kerber, Nadjib Schahab, Axel Fischer, Borries Jacques, Peter Flügel, Elias Noory, Mehmet Boral, Martin Andrassy, Ralf Kolvenbach, Thomas Zeller, Andrew Hill, Carlos Mena, Christopher Leach, Arshad Sheriff, Charles Ross, Christopher Metzger, Ellen Gebauer, Yvonne Bausback, Bharat Samy, Peter Rief, Andrew Holden, Martin Werner, Franz Hafner, Steve Henao, Abdul Halabi, Marianne Brodmann, Angelos Santos, Pradymna Tummala, Sherise Warren, Christopher Regan, Andrej Schmidt, Corneliu Popescu, Gunnar Tepe, Jeff Marshall, Edward Garrett, Vincent Santo, Michele de Gregorio, James Reeves, S. Elissa Altin
Sponsors
Leads: Shockwave Medical, Inc.

This content was sourced from clinicaltrials.gov

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