Phase
Condition
Circulation Disorders
Vascular Diseases
Intermittent Claudication
Treatment
Shockwave Intravascular Lithotripsy (IVL)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
Subject is a suitable candidate for angiography and endovascular intervention perthe latest clinical guidelines
Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at thephysician's discretion.
Angiographic Inclusion Criteria
Target lesion that is located in a native, de novo common femoral artery
Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visualestimate.
Target lesion is ≥70% stenosis by investigator via visual estimate.
Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be allor part of the 50mm treated zone.
Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
Calcification is at least moderate defined as presence of fluoroscopic evidence ofcalcification: 1) on parallel sides of the vessel and 2) extending > 50% the lengthof the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm iflesion is <50mm in length.
Exclusion
Exclusion Criteria:
Subjects with any medical condition that would make him/her an inappropriatecandidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as perInstructions for Use (IFU) or investigator's opinion.
Subject is already enrolled in other investigational (interventional) studies thatwould interfere with study endpoints.
Cognitive impairment as documented in medical records
Not speaking English or Spanish
Currently a prisoner
Pregnancy or nursing
Estimated survival less than 12 months at the time of screening
Prior history of CFA endarterectomy
Study Design
Study Description
Connect with a study center
Yale New Haven Health
New Haven, Connecticut 06510
United StatesSite Not Available
Yale New Haven Health
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
The Miriam Hospital
Providence 5224151, Rhode Island 5224323 02906
United StatesSite Not Available

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