IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD

Sponsor
IVX Medical
Study ID
NCT07747883
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • IV-X Medical IVL System — DEVICE
    The IV-X Medical Intravascular Lithotripsy (IVL) System (IV-X IVL System) is a balloon-based lithotripsy device designed to treat calcified peripheral artery lesions. The device employs sonic pressure waves to fracture the calcifications, restoring blood flow and improving vascular health.

Study Details

To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment calcified peripheral arteries (iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries).

Key Dates

First listed
Aug 5, 2026
Start date
Sep 14, 2026
Status verified
Aug 2026
Primary completion
Oct 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IVL Treatment Arm

Primary Outcome Measure

Primary Safety Endpoint defined as proportion of subjects with one or more new onset Major Adverse Events (MAEs) through 30 days post-procedure. [ Time Frame: 30 Days ]

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