Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen (NCT07575568) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
30 participantsStarted 2026-05
Plain-language summary
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
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 for Cohort A: ATK arm of the study:
Clinical:
* Subject is ≥ 18 years of age
* Target limb is Rutherford Clinical Category 2, 3 or 4
* Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb
Angiographic:
* Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
* Reference vessel diameter (RVD) between 4.0 and 8.0mm
* Target lesion must have a diameter stenosis of ≥70%
* Lesion calcification is at least moderate
* Total planned target lesion length must be ≤150mm
* Chronic total occlusion lesion length is ≤100mm
* Subject has at least one patent tibial vessel on the target limb with runoff to the foot
* Exclusion Criteria for Cohort A: ATK arm of the study:
Clinical:
* Rutherford Clinical Categories 0, 1, 5 and 6
* Subject with known pregnancy or is nursing
* Subject has acute or chronic renal disease, defined as serum creatinine of \>2.5 mg/dL or \>220 µmol/L or on dialysis
Angiographic:
* Target lesions \>150mm by visual estimation
* Chronic total occlusions \> 100mm by visual estimation
* No or mild calcium present in the target lesion
* Inclusion Criteria for Cohort B: BTK arm of the study:
Clinical:
* Age of subject is ≥18
* Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)
Angiographic:
* Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels
* Target vessel reference diameter is between 2.…
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.