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

  • End date
    Nov 15, 2027
  • participants needed
  • sponsor
    Alucent Biomedical
Updated on 4 October 2022


Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA): ACTIVATE II

Condition PAD - Peripheral Arterial Disease
Treatment Vessel Restoration System (VRS)
Clinical Study IdentifierNCT05454995
SponsorAlucent Biomedical
Last Modified on4 October 2022


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
specific test or procedures are performed and agree to attend all required follow-up
Chronic symptomatic lower limb ischemia defined as Rutherford classification 2,3, or

Exclusion Criteria

Life expectancy, documented in the Investigator's opinion, of less than 12 months
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
Known allergies or sensitivities to heparin, aspirin (ASA), other
anticoagulant/antiplatelet therapies
Known hypersensitivity or contraindication to contrast dye that, in the opinion of the
investigator, cannot be adequately pre-medicated
Chronic renal insufficiency with serum creatinine ≥2.5 mg/dL or eGFR <45 ml/min within
days of index procedure or treatment with dialysis
Receiving oral or intravenous immunosuppressive therapy
Subject has white blood cell (WBC) count < (3,000 cells/mm3) within 7 days prior to
index procedure
Subject has known or suspected active systemic infection evidenced by WBC > 14.0
History of major amputation in the target limb
Any major intervention planned at index procedure or within 30 days post-index
procedure including treatment of contralateral limb
Any arterial access other than contralateral femoral artery is required to gain access
to target vessel. Ipsilateral access is excluded
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
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
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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