Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1373 participants
OBSERVATIONAL
2017-11-16
2021-06-10
Brief Summary
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Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
3. Age of subject is \> 18.
4. Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
5. 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.
Exclusion Criteria
2. Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Stanford Hospital
Palo Alto, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
UCHealth Northern Colorado
Loveland, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tallahassee Research Institute Inc.
Tallahassee, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Cardiovascular Consultants
Kansas City, Missouri, United States
Mount Sinai West
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
NC Heart & Vascular Research, LLC
Raleigh, North Carolina, United States
Ohio Health Research Institute
Columbus, Ohio, United States
St. John Clinic
Bartlesville, Oklahoma, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Baptist Medical Center
Memphis, Tennessee, United States
St. David's Heart and Vascular (Austin Heart)
Austin, Texas, United States
Baylor Clinic McNair Campus
Houston, Texas, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Evangelisches Krankenhaus Mulheim an der Ruhr
Mülheim, , Germany
St. Franziskus Hospital
Münster, , Germany
RoMed Klinikum Rosenheim
Rosenheim, , Germany
Auckland City Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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CP 60892 OS
Identifier Type: -
Identifier Source: org_study_id
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