Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II (ACTIVATEII)

This is an interventional treatment trial for PAD - Peripheral Arterial Disease Read More

General Inclusion Criteria:

Subjects for this study must meet all of the following general eligibility criteria AND the answer must be "YES" to all general inclusion criteria:

specific test or procedures are performed and agree to attend all required follow-up visits;

• Chronic symptomatic lower limb ischemia defined as Rutherford classification 2,3, or 4;

General Exclusion Criteria

1. Life expectancy, documented in the Investigator's opinion, of less than 12 months;
2. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g. PCI for STEMI/NSTEMI, unstable angina) within 3 months prior to enrollment;
3. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies;
4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated;
5. Chronic renal insufficiency with serum creatinine ≥2.5 mg/dL or eGFR <45 ml/min within 30 days of index procedure or treatment with dialysis;
6. Receiving oral or intravenous immunosuppressive therapy;
7. Subject has white blood cell (WBC) count < (3,000 cells/mm3) within 7 days prior to index procedure.
8. Subject has known or suspected active systemic infection evidenced by WBC > 14.0 (14,000/mm3).
9. History of major amputation in the target limb;
10. Any major intervention planned at index procedure or within 30 days post-index procedure including treatment of contralateral limb;
11. Any arterial access other than contralateral femoral artery is required to gain access to target vessel. Ipsilateral access is excluded.
12. Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate, except when the subject is prescribed such medication as treatment for atrial fibrillation (medication and/or following ablation therapies)
13. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of child bearing potential must agree to use effective birth control measures for 30 days after enrollment.
14. Current or planned (within next 365 days) participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.
15. Any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol and follow-up visits