Clinical trial NCT05455021: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PAD - Peripheral Arterial Disease
Lead sponsor: Alucent Biomedical
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study is a prospective, nonrandomized, multicenter, open-label feasibility study of the VRS for the treatment of atherosclerotic de novo or restenotic lesions in the SFA and/or PA after sub-optimal PTA or atherectomy angiographic outcomes.
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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:

1. 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.
2. Male or female subject of at least 18 years of age.
3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4.
4. Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).

Exclusion Criteria:

1. Life expectancy, documented in the Investigator's opinion, of less than 1 year.
2. 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.
3. 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.
4. 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.
5. Receiving oral or intravenous immunosuppressive therapy.
6. Subject has white blood cell (WBC) count \< 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
7. History of major amputation in the target limb.
8. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
9. 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.

Primary outcomes:
measure: An acute reduction in arterial dissections
timeFrame: 12 months
measure: Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
timeFrame: 12 months
Secondary outcomes:
measure: Technical Success
timeFrame: 12 months
measure: Procedural Success
timeFrame: 12 months
measure: Clinical Success
timeFrame: 36 months
measure: Safety Measure
timeFrame: 72 months
measure: Hemodynamic Improvement
timeFrame: 36 months
measure: Rutherford Classification
timeFrame: 36 months
measure: Quality of Life Measure
timeFrame: 72 months
Other outcomes:
measure: Major Adverse Limb Events
timeFrame: 36 months
measure: Reintervention for treatment of thrombosis of the target vessel or embolization to its distal Vasculature
timeFrame: 36 months
measure: Major Vascular Complications
timeFrame: 36 months
Locations:
city: Adelaide
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
References: