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 Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- An acute reduction in arterial dissections [12 months]
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 [12 months]
Primary Patency as assessed by Doppler Ultrasound (DUS)
Secondary Outcome Measures
- Technical Success [12 months]
Technical success is defined by successful delivery of the VRS
- Procedural Success [12 months]
Procedural Success is defined as an acute reduction in arterial dissection(s)
- Clinical Success [36 months]
Clinical success is defined as freedom from CD-TLR
- Safety Measure [72 months]
Frequency of MAEs
- Hemodynamic Improvement [36 months]
Rate of hemodynamic improvement ABI
- Rutherford Classification [36 months]
As assessed by changes in Rutherford Class
- Quality of Life Measure [72 months]
Quality of life (QOL) assessment by EQ-5D
Other Outcome Measures
- 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]
Eligibility Criteria
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:
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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.
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Male or female subject of at least 18 years of age.
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Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or
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Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).
Exclusion Criteria:
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Life expectancy, documented in the Investigator's opinion, of less than 1 year.
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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.
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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.
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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.
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Receiving oral or intravenous immunosuppressive therapy.
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Subject has white blood cell (WBC) count < 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
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History of major amputation in the target limb.
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Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Flinders Medical Center | Adelaide | South Australia | Australia | |
| 2 | The Alfred Hospital | Melbourne | Victoria | Australia |
Sponsors and Collaborators
- Alucent Biomedical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1061-002