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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Flinders Medical Center
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
An acute reduction in arterial dissections
Reduction in arterial dissection(s) of at least one grade.
Time frame: 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)
Time frame: 12 months
Technical Success
Technical success is defined by successful delivery of the VRS
Time frame: 12 months
Procedural Success
Procedural Success is defined as an acute reduction in arterial dissection(s)
Time frame: 12 months
Clinical Success
Clinical success is defined as freedom from CD-TLR
Time frame: 36 months
Safety Measure
Frequency of MAEs
Time frame: 72 months
Hemodynamic Improvement
Rate of hemodynamic improvement ABI
Time frame: 36 months
Rutherford Classification
As assessed by changes in Rutherford Class
Time frame: 36 months
Quality of Life Measure
Quality of life (QOL) assessment by EQ-5D
Time frame: 72 months
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