Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Les… (NCT05455021) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Australia50 participantsStarted 2021-11-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
An acute reduction in arterial dissections
Timeframe: 12 months
2
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year