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

NCT05455021 | Active Not Recruiting DMC

• 1 other identifier: 1061-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

PAD - Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• An acute reduction in arterial dissections

  Reduction in arterial dissection(s) of at least one grade.

  12 months

• Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year

  Primary Patency as assessed by Doppler Ultrasound (DUS)

  12 months

Secondary Outcomes (7)

• Technical Success

  12 months

• Procedural Success

  12 months

• Clinical Success

  36 months

• Safety Measure

  72 months

• Hemodynamic Improvement

  36 months

Other Outcomes (3)

• Major Adverse Limb Events

  36 months

• Reintervention for treatment of thrombosis of the target vessel or embolization to its distal Vasculature

  36 months

• Major Vascular Complications

  36 months

Interventions

Vessel Restoration System (VRS) COMBINATION_PRODUCT

The VRS includes the following components: * VRS 10-8-10 Dimer Coated Balloon Catheter * VRS Light Fiber * VRS Light Source The VRS will collectively refer to all the components used to perform the procedure. Their specific product name will identify individual elements.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects for this study must meet all of the following general eligibility 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alucent Biomedical: lead

Study Sites (2)

Flinders Medical Center

Adelaide, South Australia, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: November 15, 2021
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)