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

NCT07575568 | Not Yet Recruiting FDA Device

• 1 other identifier: CSP-1179
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Freedom from Major Adverse Events at 6 months

  6 months

• Freedom from Major Adverse Events at 12 months

  12 months

• Procedural success of ≤30% residual stenosis of the target lesion

  Procedure

• Patency rates of target lesion by duplex ultrasound

  30 Days, 6 Months, and 12 Months

• Freedom from clinically-driven target lesion revascularization

  30 Days, 6 Months, and 12 Months

Study Arms (2)

Above-the-Knee

EXPERIMENTAL

For blockages in the legs that occur above the knee.

Device: Serranator Sonic Intravascular Lithotripsy (IVL) System

Below-the-Knee

EXPERIMENTAL

For blockages in the legs that occur below the knee.

Device: Serranator Sonic Intravascular Lithotripsy (IVL) System

Interventions

Serranator Sonic Intravascular Lithotripsy (IVL) System DEVICE

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.

Above-the-Knee; Below-the-Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• Cagent Vascular LLC: lead
• Clinical Accelerator: collaborator
• Australian Healthcare Solutions: collaborator
• Yale Cardiovascular Research Group: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Alexis Shewfelt

CONTACT

650-208-6743; ashewfelt33@cagentvascular.com

Jennifer Meyers Sullivan

CONTACT

219-730-9402; jsullivan64@cagentvascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients can have a lesion above the knee treated or up to 2 lesions below the knee treated.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05