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NCT07575568

Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Sponsor: Cagent Vascular LLC

View on ClinicalTrials.gov

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.

Official title: REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05

Completion Date

2027-09

Last Updated

2026-05-08

Healthy Volunteers

Conditions

Peripheral Artery Disease

Interventions

DEVICE

Serranator Sonic Intravascular Lithotripsy (IVL) System

Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.

\*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 2.5mm and 4.0 mm * Target lesion with diameter stenosis ≥50% * Target lesion is ≤150mm in length * Subject has at least one patent tibial vessel (\>50%) with run-off to the foot. * Calcification is at least moderate * Exclusion Criteria for Cohort B: BTK arm of the study: Clinical: * Rutherford Clinical Category 0,1 or 6 * Gangrene of the lower extremity * Patient is pregnant or nursing Angiographic: * Target lesion is within only lower extremity vessel with \< 50% stenosis * Target lesion length exceeds 150mm * Patient has chronic total occlusion of target lesion