Back to resultsFeasibility 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)
Primary Purpose
PAD - Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Vessel Restoration System (VRS)
Sponsored by
About this trial
This is an interventional treatment trial for PAD - Peripheral Arterial Disease
Eligibility Criteria
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:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- Flinders Medical CenterRecruiting
- The Alfred HospitalRecruiting
Outcomes
Primary Outcome Measures
An acute reduction in arterial dissections
Reduction in arterial dissection(s) of at least one grade.
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
Primary Patency as assessed by Doppler Ultrasound (DUS)
Secondary Outcome Measures
Technical Success
Technical success is defined by successful delivery of the VRS
Procedural Success
Procedural Success is defined as an acute reduction in arterial dissection(s)
Clinical Success
Clinical success is defined as freedom from CD-TLR
Safety Measure
Frequency of MAEs
Hemodynamic Improvement
Rate of hemodynamic improvement ABI
Rutherford Classification
As assessed by changes in Rutherford Class
Quality of Life Measure
Quality of life (QOL) assessment by EQ-5D
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05455021
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
November 15, 2026 (Anticipated)
Study Completion Date
November 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alucent Biomedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAD - Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Combination Product
Intervention Name(s)
Vessel Restoration System (VRS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
An acute reduction in arterial dissections
Description
Reduction in arterial dissection(s) of at least one grade.
Time Frame
12 months
Title
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
Description
Primary Patency as assessed by Doppler Ultrasound (DUS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical Success
Description
Technical success is defined by successful delivery of the VRS
Time Frame
12 months
Title
Procedural Success
Description
Procedural Success is defined as an acute reduction in arterial dissection(s)
Time Frame
12 months
Title
Clinical Success
Description
Clinical success is defined as freedom from CD-TLR
Time Frame
36 months
Title
Safety Measure
Description
Frequency of MAEs
Time Frame
72 months
Title
Hemodynamic Improvement
Description
Rate of hemodynamic improvement ABI
Time Frame
36 months
Title
Rutherford Classification
Description
As assessed by changes in Rutherford Class
Time Frame
36 months
Title
Quality of Life Measure
Description
Quality of life (QOL) assessment by EQ-5D
Time Frame
72 months
Other Pre-specified Outcome Measures:
Title
Major Adverse Limb Events
Time Frame
36 months
Title
Reintervention for treatment of thrombosis of the target vessel or embolization to its distal Vasculature
Time Frame
36 months
Title
Major Vascular Complications
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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).
Exclusion Criteria:
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.
Facility Information:
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Toomey
Phone
08 82045445
Email
Melanie.Toomey@SA.gov.au
First Name & Middle Initial & Last Name & Degree
Chris Delaney, MD
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Kavoudias, PhD
Phone
+ 61 3 9076 3606
Email
H.KAvnoudia@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Gerard Goh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not sharing IPD
Learn more about this trial
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
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