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) Systemâ„¢ for the treatment of peripheral artery disease.
Who can participate
Age range18 Years
SexALL
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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.…