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

PAD - Peripheral Arterial Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05455021
• Other study ID #: 1061-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: November 15, 2026

Study information

• Verified date: January 2024
• Source: Alucent Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• PAD - Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Combination Product:
• Vessel Restoration System (VRS)
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.

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Adelaide	South Australia
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Alucent Biomedical

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Adverse Limb Events		36 months
Other	Reintervention for treatment of thrombosis of the target vessel or embolization to its distal Vasculature		36 months
Other	Major Vascular Complications		36 months
Primary	An acute reduction in arterial dissections	Reduction in arterial dissection(s) of at least one grade.	12 months
Primary	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	Technical Success	Technical success is defined by successful delivery of the VRS	12 months
Secondary	Procedural Success	Procedural Success is defined as an acute reduction in arterial dissection(s)	12 months
Secondary	Clinical Success	Clinical success is defined as freedom from CD-TLR	36 months
Secondary	Safety Measure	Frequency of MAEs	72 months
Secondary	Hemodynamic Improvement	Rate of hemodynamic improvement ABI	36 months
Secondary	Rutherford Classification	As assessed by changes in Rutherford Class	36 months
Secondary	Quality of Life Measure	Quality of life (QOL) assessment by EQ-5D	72 months