None listed
Conditions
Brief 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.
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, aque
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.
Sponsors
Tetherx, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed