Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen (REMODEL I)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Serranator Sonic Intravascular Lithotripsy (IVL) System

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis Shewfelt; Phone Number: 650-208-6743; Email: ashewfelt33@cagentvascular.com
• Study Contact Backup: Name: Jennifer Meyers Sullivan; Phone Number: 219-730-9402; Email: jsullivan64@cagentvascular.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

*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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Above-the-Knee; For blockages in the legs that occur above the knee.	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.
Experimental: Below-the-Knee; For blockages in the legs that occur below the knee.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety: Major Adverse Events	Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of: All cardiovascular death; Major amputation; Clinically-driven target lesion revascularization (CD-TLR)	30 Days
Primary Effectiveness: Procedural Success	Procedural Success, defined as: <50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Major Adverse Events at 6 months	Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization	6 months
Freedom from Major Adverse Events at 12 months	Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization.	12 months
Procedural success of ≤30% residual stenosis of the target lesion	Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment	Procedure
Patency rates of target lesion by duplex ultrasound	Patency rates at 30 days, 6 months, and 12 months of target lesion by duplex ultrasound. Target vessel patency by duplex ultrasound, defined as freedom from > 50% restenosis, as assessed by duplex ultrasound peak systolic velocity ratio of ≥2.5	30 Days, 6 Months, and 12 Months
Freedom from clinically-driven target lesion revascularization	Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months	30 Days, 6 Months, and 12 Months
Change in Ankle-Brachial Index/Toe-Brachial Index	Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline	30 Days, 6 Months, and 12 Months
Change in Rutherford Category	Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline	30 Days, 6 Months, and 12 Months
Change in Walking Impairment Questionnaire score	Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline	30 Days, 6 Months, and 12 Months
Change in EuroQol-5D-3L	Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline	30 Days, 6 Months, and 12 Months

Collaborators and Investigators

• Sponsor: Cagent Vascular LLC
• Collaborators: Yale Cardiovascular Research Group; Clinical Accelerator; Australian Healthcare Solutions

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: CSP-1179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes