Evaluating Shockwave Intravascular Lithotripsy for Calcified Femoral Arteries
CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
This study is testing if a new shockwave treatment can help people with blocked femoral arteries due to calcium buildup feel better and improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05145478 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with claudication or critical limb ischemia who are scheduled for angiography and endovascular intervention.
Not a fit: Patients with lesions not meeting the specified criteria or those who are not suitable for angiography may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and health outcomes for patients with calcified femoral artery disease.
How similar studies have performed: Previous studies using similar IVL technology have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.