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)

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 Overview

• Status: Active, not recruiting
• Conditions: PAD - Peripheral Arterial Disease
• Intervention / Treatment: Combination product: Vessel Restoration System (VRS)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia
      • Flinders Medical Center
  • Victoria
    • Melbourne, Victoria, Australia
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	Technical success is defined by successful delivery of the VRS	12 months
Procedural Success	Procedural Success is defined as an acute reduction in arterial dissection(s)	12 months
Clinical Success	Clinical success is defined as freedom from CD-TLR	36 months
Safety Measure	Frequency of MAEs	72 months
Hemodynamic Improvement	Rate of hemodynamic improvement ABI	36 months
Rutherford Classification	As assessed by changes in Rutherford Class	36 months
Quality of Life Measure	Quality of life (QOL) assessment by EQ-5D	72 months

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alucent Biomedical

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 1061-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not sharing IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No