CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

Launched by YALE UNIVERSITY · Dec 2, 2021

Keywords

ClinConnect Summary

The CRUSH PAD clinical trial is studying the use of a new treatment called Shockwave Intravascular Lithotripsy (IVL) for patients with hardening of the arteries in the thigh area, specifically in the common femoral artery. This trial aims to find out how effective this technology is in improving blood flow and overall health in people who have conditions like peripheral artery disease, which can cause leg pain and other serious issues. The study is currently looking for participants aged 65 to 74 who have certain symptoms of reduced blood flow in their legs and are eligible for a specific type of treatment.

To join the trial, participants need to have significant narrowing in their femoral arteries and must be scheduled for IVL treatment followed by standard care options, such as balloon angioplasty. Participants can expect to receive the IVL treatment to help break up the calcified plaque in their arteries, which aims to improve blood flow and reduce symptoms. It's important to note that those with certain medical conditions, cognitive impairments, or who are currently pregnant or nursing are not eligible for this trial. By joining, participants will help researchers gather valuable information that could improve future treatments for similar conditions.

Gender

ALL

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