Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I (REACTIVATE I)

  • STATUS
    Recruiting
  • End date
    Nov 15, 2026
  • participants needed
    50
  • sponsor
    Alucent Biomedical
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Updated on 4 October 2022
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Summary

Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I

Details
Condition PAD - Peripheral Arterial Disease
Treatment Vessel Restoration System (VRS)
Clinical Study IdentifierNCT05455021
SponsorAlucent Biomedical
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits
Male or female subject of at least 18 years of age
Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4\
Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s)

Exclusion Criteria

Life expectancy, documented in the Investigator's opinion, of less than 1 year
Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI/NSTEMI, unstable angina) within 6 months prior to the index procedure
Chronic renal insufficiency with serum creatinine ≥ 2.5 mg/dL or eGFR <45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis
Receiving oral or intravenous immunosuppressive therapy
Subject has white blood cell (WBC) count < 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure
History of major amputation in the target limb
Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb
Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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