The Tetherx Natural Vascular Scaffolding (NVS) Procedure for Treating Patients with Atherosclerosis of the Femoropopliteal Artery
This is a prospective, single-center, first-in-man, proof-of-concept study to be conducted at Auckland City Hospital, Auckland, New Zealand to evaluate the safety and performance of the Tetherx NVS System in subjects with femoropopliteal atherosclerosis, Rutherford category 2-4.
Tetherx, Inc.
30 participants
Jul 11, 2011
Interventional
Conditions
Summary
The primary objective of this study is to evaluate the acute and post-procedural safety through 12 months of the Tetherx NVS therapy in the treatment of superficial femoral or proximal popliteal atherosclerotic disease.
Eligibility
Inclusion Criteria7
- I1 Age > 18 years and < 85 years
- I2 Subject 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
- I3 Female 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
- I4 Subject understands the duration of the study and its follow up visit requirements
- I5 Subject has documented claudication or ischemic rest pain in the target limb prior to the study procedure with documented Rutherford category 2, 3, or 4
- I6 Subject is able to walk unassisted
- I7 Subject has a documented resting ABI < 0.9 or a toe brachial index (TBI) performed (if ABI non-diagnostic) prior to enrollment
Exclusion Criteria12
- I1 Life expectancy < 12 months (in the Investigator’s opinion)
- I2 Debilitating cerebrovascular accident (CVA) or ST Segment Myocardial Infarction (STEMI) within the 3 months prior to enrollment
- I3 Administration of local systemic thrombolytics for acute limb ischemia (ALI) within the previous 30 days
- I4 Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or the NVS vascular polyethylene glycol (PEG) solution
- I5 Allergy to contrast media that cannot be adequately pre-treated prior to procedure
- I6 Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
- I7 Untreatable bleeding diatheses, hypercoagulable state, thrombocytopenia, and/or other bleeding disorder unresponsive to or not improved by blood transfusion
- I8 Systemic infection present or suspected
- I9 Enrolled in another investigational device, drug, or biologic study in which the subject has not completed the follow-up requirements
- I10 There is an additional planned percutaneous intervention (cardiac/peripheral) < 30 days following the study procedure
- I11 Subject is breast-feeding or plans to become pregnant during the follow-up period
- I12 Previous lower limb amputation, excluding toe amputations
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Interventions
The use of the NVS balloon catheter in clinical practice is the same as other percutaneous transluminal angioplasty (PTA) balloon catheters used to perform balloon angioplasty. The steps of the NVS procedure include: 1) Inflate both occlusion balloons so that the treatment zone (length of the artery between both occlusion balloons) is isolated. Keep the occlusion balloons inflated for the duration of the procedure. 2) Inject the NVS Solution - which is a polyethylene-glycol (PEG)-based, aqueous solution - in between the 2 inflated occlusion balloons. This will enable the NVS solution to diffuse into the vessel wall. The duration to let the NVS Solution diffuse into the vessel wall is 5 minutes. 3) Inflate the balloon in between the 2 occlusion balloons; this is the Treatment Zone Balloon. Keep the Treatment Zone Balloon inflated for the duration of the light activation (see step below - i.e. 60 seconds). 4) Activate the light fiber that runs through the catheter so that blue light (light with wavelength of 444-457nm) activates the NVS Solution; the duration to activate the light fiber is 60 seconds. Note that the lumen in the catheter that the light fiber is in has a saline drip attached to it which enables a constant flow of saline to mitigate any risk of heat transferring from the light fiber to the catheter lumen, balloon or vessel. 5) Deflate the Occlusion Balloons and the Treatment Zone Balloons and remove the NVS Delivery Catheter. The NVS Treatment is now complete. The duration of the procedure is between 8-10 minutes.
Locations(1)
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ACTRN12611000897965