Actively Recruiting
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
52 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
This research aims to evaluate the outcomes of using Shockwave Intravascular Lithotripsy (IVL) technology in patients with peripheral artery disease who have calcified common femoral artery lesions. The study focuses on measuring health status improvements and treatment effectiveness in routine clinical practice, as well as gathering preliminary data for future comparative research. It also investigates procedural success and disease progression in these patients. Eligible patients with atherosclerotic femoral artery lesions causing claudication or critical limb ischemia will receive endovascular treatment including the use of Shockwave IVL technology. This device-based treatment is followed by standard care, which may include drug-coated balloons or stents, at the physician's discretion. The study observes outcomes immediately after the procedure and over a long-term follow-up period. Participants will be monitored through health status assessments at baseline, 30 days, 6 months, and up to 12 months. Researchers will track procedural success, target lesion revascularization rates, adverse events, and clinical improvements. Data collection includes patient evaluations during admission and follow-ups to understand the safety and effectiveness of IVL treatment in real-world clinical settings. Total participation duration can extend up to 12 months.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Presenting with claudication or critical limb ischemia (Rutherford Clinical Category 2 to 6) in the target limb
- Suitable candidate for angiography and endovascular intervention per clinical guidelines
- Scheduled to receive treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard care treatment with drug-coated balloons or stents
- Target lesion located in a native, de novo common femoral artery
- Target lesion reference vessel diameter between 4.0 mm and 7.0 mm
- Target lesion stenosis of 50% or greater by visual estimate
- Target lesion length 50 mm or less for lesions 70-99% stenosed
- Chronic total occlusion lesion length 50 mm or less
- Calcification at least moderate with fluoroscopic evidence on parallel sides of the vessel extending at least 50% of lesion length if lesion is 50 mm or longer, or minimum 20 mm if lesion is shorter than 50 mm
You will not qualify if you...
- Medical conditions making treatment with Shockwave Medical Peripheral Lithoplasty System inappropriate as judged by instructions for use or investigator
- Currently enrolled in other investigational interventional studies that interfere with study endpoints
- Documented cognitive impairment
- Not fluent in English or Spanish
- Currently a prisoner
- Pregnant 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive treatment with the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions as part of routine clinical practice.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for health status changes, procedural success, and adverse events following the IVL treatment.
Follow-up visits at 30 days, 6 months, and 12 months
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here