Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial (NCT06457685) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Amplitude Vascular Systems (AVS) Lithotripsy POWER PAD 2 Trial
United States115 participantsStarted 2024-09-05
Plain-language summary
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular Systems (AVS) Pulse Intravascular Lithotripsyâ„¢ (Pulse IVLâ„¢) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able and willing to comply with all assessments in the study.
✓. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
✓. \>18 years old
✓. Rutherford Clinical Category 2, 3, or 4 of the target limb
✓. Resting ankle-brachial index (ABI) of ≤0.90, or ≤0.75 after exercise, of the target leg OR ≥70% stenosis by prior imaging (CT/MR angiogram, DUS).
✓. Subjects has de novo lesions who are felt to have indication for peripheral angiography and endovascular intervention by the investigator per their standard of care.
✓. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening.
✓. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
Exclusion criteria
✕. Rutherford Clinical Category 0, 1, 5 and 6.
✕. Active infection in the target leg.
✕. Planned major amputation of the target leg (transmetatarsal or higher).
✕. History of prior endovascular or surgical procedure on the target limb within the past 30 days.
✕. Retrograde pedal/tibial access for intervention.
✕. Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5.
✕. Lesion in contralateral limb requiring intervention within the next 30 days.
✕. Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy.