Evaluating Shockwave Intravascular Lithotripsy for Calcified Femoral Arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the real-world outcomes of using Shockwave Intravascular Lithotripsy (IVL) technology in patients with peripheral artery disease who have calcified common femoral lesions. It will collect data on health status improvements and procedural success rates following IVL treatment. The study will focus on endpoints such as target lesion revascularization and overall health status, using the EQ5D scale to measure clinically significant changes. The findings will help inform future comparative effectiveness research in this area.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale New Haven Health
  New Haven, Connecticut, United States Recruiting
• The Miriam Hospital
  Providence, Rhode Island, United States Not yet recruiting

Study contacts

• Principal investigator: Carlos Mena-Hurtado, MD — Yale University
• Study coordinator: Kim Smolderen, PhD
• Email: kim.smolderen@yale.edu
• Phone: 203-737-7673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.