RecruitingEarly Phase 1ACTRN12611000897965

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.

Sponsor

Tetherx, Inc.

Enrollment

30 participants

Start Date

Jul 11, 2011

Study Type

Interventional

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).

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment for blocked arteries in the leg called the Tetherx Natural Vascular Scaffolding (NVS) procedure. Blocked leg arteries cause leg pain when walking (claudication) or even pain at rest. The procedure uses a special solution to support the artery from the inside without a metal stent. Participants will be monitored for 12 months for safety and effectiveness. You may be eligible if: - You are between 18 and 85 years old - You have leg pain from artery blockage (claudication or rest pain) rated Rutherford category 2, 3, or 4 - You can walk without assistance - You have a documented low ankle-brachial index (poor blood pressure in the foot compared to the arm) You may NOT be eligible if: - Your life expectancy is less than 12 months - You have had a stroke or heart attack in the last 3 months - You are allergic to heparin, aspirin, or the solution used in the procedure - You have severe kidney problems (creatinine above 2.5 mg/dL) - You have had a previous lower-limb amputation (other than a toe) - You are pregnant or planning to become pregnant Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

New Zealand

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ACTRN12611000897965