CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Recruiting now
Conditions studied: Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
In brief
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.
Key facts
- Study ID
- NCT05145478
- Run by
- Yale University
- People needed
- 50
- Starts
- 2021-12-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 per the 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 the physician'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 visual estimate.
- Target lesion is ≥70% stenosis by investigator via visual estimate.
- Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or 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 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.
You may not qualify if…
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
- Subject is already enrolled in other investigational (interventional) studies that would 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
Where it is running
- Yale New Haven Health — New Haven, Connecticut, United States (enrolling)
- The Miriam Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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