CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technol… (NCT05145478) | Clinical Trial Compass
RecruitingNot Applicable
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
United States50 participantsStarted 2021-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (interventi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.