The Tetherx Natural Vascular Scaffolding (NVS) Procedure for Treating Patients with Atherosclerosis of the Femoropopliteal Artery
- Conditions
- Symptoms of claudication or ischemic rest pain (Rutherford category 2, 3, or 4) with suspected atherosclerosis in either the superficial femoral artery or the proximal popliteal artery (above the knee articulation).Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12611000897965
- Lead Sponsor
- Tetherx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
I1Age > 18 years and < 85 years
I2Subject or subject’s legal representative have been informed of the nature of the study, agrees to participate and has signed an EC approved consent form
I3Female subjects of childbearing potential have a negative pregnancy test at 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
I4Subject understands the duration of the study and its follow up visit requirements
I5Subject has documented claudication or ischemic rest pain in the target limb prior to the study procedure with documented Rutherford category 2, 3, or 4
I6Subject is able to walk unassisted
I7Subject has a documented resting ABI < 0.9 or a toe brachial index (TBI) performed (if ABI non-diagnostic) prior to enrollment
I1Life expectancy < 12 months (in the Investigator’s opinion)
I2Debilitating cerebrovascular accident (CVA) or ST Segment Myocardial Infarction (STEMI) within the 3 months prior to enrollment
I3Administration of local systemic thrombolytics for acute limb ischemia (ALI) within the previous 30 days
I4Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or the NVS vascular polyethylene glycol (PEG) solution
I5Allergy to contrast media that cannot be adequately pre-treated prior to procedure
I6Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
I7Untreatable bleeding diatheses, hypercoagulable state, thrombocytopenia, and/or other bleeding disorder unresponsive to or not improved by blood transfusion
I8Systemic infection present or suspected
I9Enrolled in another investigational device, drug, or biologic study in which the subject has not completed the follow-up requirements
I10There is an additional planned percutaneous intervention (cardiac/peripheral) < 30 days following the study procedure
I11Subject is breast-feeding or plans to become pregnant during the follow-up period
I12Previous lower limb amputation, excluding toe amputations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety as determined by either angiographic criteria or duplex ultrasonography criteria in the presence of return of symptoms (an increase in the Rutherford Classification by greater than 1 category) and/or decline in rest Ankle Brachial Indices from the post-procedure baseline value.[During the procedure and immediately following the procedure (acute) and 30 days.];Freedom from index limb amputation; method of assessment is clinical assessments.[During the procedure and immediately following the procedure (acute) and 30 days.];Freedom from clinically-driven target lesion revascularization (TLR); method of assessment is clinical assessments and Duplex Doppler Ultrasound.[During the procedure and immediately following the procedure (acute) and 30 days.]
- Secondary Outcome Measures
Name Time Method Efficacy as determined by a Duplex Ultrasound (DUS) Peak systolic velocity ratio (PSVR) and freedom from clinically-driven target lesion revascularization. Clinically-driven is defined as either a PSVR greater than or equal to 2.5 or visually estimated angiographic percent DS greater than 70% and one of the following: an increase in the Rutherford Classification by greater than 1 category from the 30 day post-intervention Rutherford Classification and/or a decline in rest Ankle Brachial Index (ABI) of greater than 0.15 from post-procedure baseline value[Post intervention at 30 days, 6 months and 12 months.];Freedom from clinically-driven target lesion revascularization (TLR). Method of assessment is Duplex Doppler Ultrasound.[6 months and 12 months.]