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

Sponsor
Cagent Vascular LLC
Study ID
NCT07575568
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 8, 2026
Start date
May 31, 2026
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Above-the-Knee
    For blockages in the legs that occur above the knee.
  • Experimental: Below-the-Knee
    For blockages in the legs that occur below the knee.

Primary Outcome Measure

Primary Safety: Major Adverse Events [ Time Frame: 30 Days ]

Central Contacts

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