IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD
ConditionPeripheral Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIVX Medical
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of subject is >18.
ATK: 2, 3, or 4
BTK: 4 or 5 (Category 5 will only include patients with ulcers not extending proximal to the metatarsal head)
Estimated life expectancy >1 year in the opinion of the investigator at the time of enrollment.
Disqualifiers
Rutherford Clinical Category 0, 1, or 5 with ulcers extending proximal to the metatarsal head, Category 6, or physically unable to ambulate (e.g., bedridden).
Subject has active infection requiring IV antibiotics in the target leg.
Planned major amputation of the target leg (above the ankle joint or higher).
Prior endovascular or surgical procedure on the index limb within the 30 days prior to enrollment (including thrombolysis).
Trial design
Design model
Single group
Treatments tested in this trial
IV-X Medical IVL System
DeviceThe 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: IVL Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint defined as proportion of subjects with one or more new onset Major Adverse Events (MAEs) through 30 days post-procedure.
Major Adverse Events (MAEs) are defined as: * Clinically driven target limb revascularization * Unplanned amputation of the target limb above the ankle * Device- or procedure-related post-operative death
Time frame
30 Days2
Primary Effectiveness Endpoint defined as the number of subjects with post-procedure residual diameter stenosis of <50% (after adjunctive therapy, if used), as assessed by quantitative angiography.
Time frame
Day of procedureSecondary outcomes
1
Secondary Endpoint of Acute Procedural Success with Freedom from Procedural Major Adverse Events.
Defined as the number of patients with BOTH post-procedure residual diameter stenosis of \<50% (without adjunctive therapy and/or stenting, if used) as assessed by Investigator via visual estimate and freedom from procedural major adverse events.
Time frame
Day of Procedure2
Secondary Endpoint of Acute Procedural Success defined as number of procedures with successful IVL treatment delivery in desired location using 2 or fewer catheters.
Time frame
Day of Procedure3
Secondary Safety Endpoint defined as the proportion of subjects with one or more device- or procedure-related adverse events (AEs) or serious adverse events (SAEs) through 30 days post-procedure.
Time frame
30 Days4
Secondary Safety Endpoint defined as freedom from clinically driven target lesion revascularization (TLR-lesion) at 30 days.
Time frame
30 DaysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: