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
Qualifiers
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
Treatments tested in this trial
- IV-X Medical IVL System
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov