Peripheral Arterial Disease (PAD)
Conditions
Keywords
PAD, Intravascular Lithotripsy, Lithotripsy, IVL, PAD II, PAD 2, Pulse IVL, Pulsatile Lithotripsy
Brief 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 Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Detailed description
POWER PAD 2 is a prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease. This study will enroll subjects \>18 years old that are presenting for a peripheral arterial disease intervention for the treatment of peripheral artery disease. Specifically, the subject has moderate to heavily calcified superficial femoral and popliteal arteries, presenting with Rutherford Category 2 to 4 of the target limb, with a reference vessel diameter (RVD) of 4mm to 6.5mm and a total lesion length of ≤ 150mm. Up to 120 subjects will be treated in the study at up to 20 U.S. investigational sites. Subjects will be evaluated at discharge, 30 days and 6 months after procedure.
Interventions
The Pulse Intravascular Lithotripsy (Pulse IVL) System is used for the treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Sponsors
Amplitude Vascular Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, single-arm, multicenter, non-randomized clinical study designed to demonstrate the safety and effectiveness of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified (moderate to severe), stenotic, superficial femoral and popliteal arteries in patients with peripheral arterial disease.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria Candidates will be included in the study only if all of the following conditions are met: 1. Able and willing to comply with all assessments in the study. 2. 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. 3. \>18 years old 4. Rutherford Clinical Category 2, 3, or 4 of the target limb 5. 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). 6. 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. 7. Estimated life expectancy \>1 year, in the opinion of the investigator at the time of screening. Angiographic Inclusion Criteria Candidates will be included in the study only if all of the following intraoperative conditions are met: 1. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline. 2. Target lesion that is located in a native de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to 2 cm above the bifurcation, or trifurcation, of the tibial artery). 3. Target lesion reference vessel diameter is between 4.0 mm and 6.5 mm by visual estimate. 4. Target zone is ≤ 150 mm in total contiguous treatable length. Target lesion can be all or part of the 150 mm zone. 5. Target lesion is ≥70% stenosis via visual estimate. 6. Subject has at least one patent tibial vessel on the target leg with runoff to the ankle (not supported by collateral circulation.) Tibial vessel patency is defined as no stenosis \>50%. 7. Ability to pass the guidewire across the atherosclerotic lesion, without the use of re-entry devices. 8. No evidence of aneurysm or acute or chronic thrombus in target vessel. 9. Calcification is at least moderate. (Presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending ≥ 50% the length of the lesion.) General
Exclusion criteria
Candidates will be excluded from the study if any of the following conditions are present: 1. Rutherford Clinical Category 0, 1, 5 and 6. 2. Active infection in the target leg. 3. Planned major amputation of the target leg (transmetatarsal or higher). 4. History of prior endovascular or surgical procedure on the target limb within the past 30 days. 5. Retrograde pedal/tibial access for intervention. 6. Known coagulopathy or has a bleeding diathesis, thrombocytopenia with platelet count \< 100,000/microliter, or International Normalized Ratio (INR) \>1.5. 7. Lesion in contralateral limb requiring intervention within the next 30 days. 8. Subject contraindicated for antiplatelet, anticoagulant, or thrombolytic therapy. 9. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 10. Known allergy to any Pulse IVL product materials. 11. Clinically significant myocardial infarction within 60 days prior to enrollment. 12. History of stroke within 60 days prior to enrollment. 13. History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to enrollment. 14. History of thrombolytic therapy within two weeks of enrollment. 15. Acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on dialysis. 16. Pregnant or nursing. 17. Participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 18. Other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of New Onset Major Adverse Events (MAE) | Within 30-days of procedure | MAE defined as experiencing any of the following: • The need for emergency surgical revascularization of target limb * Unplanned target limb amputation (above the ankle) * Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization. * Perforations or dissections of grade D or greater that require an intervention such as bailout stenting. |
| Procedural Success | Time Frame: Day of procedure | Defined as: The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (after adjunctive therapy, if used) as assessed by quantitative angiography via core lab evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Day of procedure | The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (prior to adjunctive therapy) as assessed by quantitative angiography via core lab evaluation. |
| Clinical Success | Day of procedure | The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to achieve a post Pulse IVL residual diameter stenosis of \<50% (after adjunctive therapy, if used) as assessed by quantitative angiography via core lab evaluation and freedom from major adverse events that occur during the procedure. |
| Clinically Driven Target Lesion Revascularization | Within 30 days and six months of procedure | Freedom from clinically driven target vessel revascularization as assessed by clinical presentation and diagnostic imaging. |
| Patency | Within 30 days and six months of procedure | Target vessel patency by Duplex ultrasound, defined as freedom from \> 50% restenosis, as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5. |
| Technical Success | Day of procedure | The ability of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy (Pulse IVL) System to deliver the Pulse IVL treatment to the desired location in the target vessel. |
| Ankle Brachial Index (ABI) | Within 30 days and six months of procedure | Change in Ankle Brachial Index (ABI) of the target limb from baseline to follow-up |
| Walking Impairment Questionnaire (WIQ) | Within 30 days and six months of procedure | Change in WIQ from baseline to follow-up |
| Freedom from major adverse events | Six months | Freedom from major adverse events |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher Metzger, MD
Ohio Health
Outcome results
None listed