NCT05145478 CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
| NCT ID | NCT05145478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Femoral Arterial Calcification |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 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. Exclusion Criteria: * 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
Contact & Investigator
Carlos Mena-Hurtado, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05145478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Femoral Arterial Calcification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05145478 currently recruiting?
Yes, NCT05145478 is actively recruiting participants. Contact the research team at kim.smolderen@yale.edu for enrollment information.
Where is the NCT05145478 trial being conducted?
This trial is being conducted at New Haven, United States, Providence, United States.
Who is sponsoring the NCT05145478 clinical trial?
NCT05145478 is sponsored by Yale University. The principal investigator is Carlos Mena-Hurtado, MD at Yale University. The trial plans to enroll 50 participants.