Actively Recruiting
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Led by Yale University · Updated on 2025-11-05
50
Participants Needed
2
Research Sites
286 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with claudication or critical limb ischemia classified as Rutherford Clinical Category 2, 3, 4, 5, or 6 in the target limbs
- Suitable candidate for angiography and endovascular intervention per current clinical guidelines
- Scheduled for treatment with Shockwave Intravascular Lithotripsy (IVL) followed by standard care with drug-coated balloons, bare metal stents, or drug-eluting stents
- Target lesion located in native, de novo common femoral artery
- Target lesion reference vessel diameter between 4.0mm and 7.0mm by visual estimate
- Target lesion has at least 70% stenosis by visual estimate
- Target lesion length up to 50mm for lesions with 70-99% stenosis
- Chronic total occlusion lesion length up to 50mm
- Calcification is moderate or higher, involving both sides of the vessel and extending more than 50% of lesion length if lesion is 50mm or longer, or at least 20mm if lesion is less than 50mm
You will not qualify if you...
- Medical conditions making treatment with Shockwave Medical Peripheral Lithoplasty System inappropriate
- Enrollment in other interventional investigational studies interfering with study endpoints
- Documented cognitive impairment
- Not speaking English or Spanish
- Currently a prisoner
- Pregnancy or nursing
- Estimated survival less than 12 months at screening
- Prior history of common femoral artery endarterectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Yale New Haven Health
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Not Yet Recruiting
Research Team
K
Kim Smolderen, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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