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

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

November 15, 2026

Study Completion Date

November 15, 2026

Conditions
PAD - Peripheral Arterial Disease
Interventions
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."

Trial Locations (2)

Unknown

Flinders Medical Center, Adelaide

The Alfred Hospital, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alucent Biomedical

INDUSTRY

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 | Biotech Hunter | Biotech Hunter