In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Stent
Use of the IDEV Supera nitinol SFA sten for the treatemnt of peripheral artery disease (Heart / Stent)
The primary objective of this study is to evaluate the safety and effectiveness of the IDev SUPERA® nitinol SFA stent for the treatment of peripheral artery disease (narrowing in the arteries that supply blood to the leg/s).
Age ≥ 18 years and of age of legal consent.
Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.
Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ABI ≤ 0.9. Resting TBI is performed only if unable to reliably assess ABI. TBI must be ≤ 0.7. These assessments are required for the target limb, but both limbs are perferred.
A single superficial femoral artery lesion with >60% stenosis or total occlusion.
Stenotic lesion(s) or occluded length within the same vessel (one long or multiple
serial lesions) ≥ 40 mm to ≤ 140 mm. Reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 6.0 mm by visual assessment.
All lesions are to be located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2cm below the origin of the profunda artery.
Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
The target lesion(s) can be successfully crossed with a guide wire and dilated.
Poor aortoiliac or common femoral “inflow” (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as <30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, the residual pressure gradient across the target lesion will be obtained and if the peak to peak pressure gradient is ≤ 20 mmHg, then the subject will be included in the study.
A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator’s discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure (staged); however, if contra-lateral treatment is performed prior to treatment of the target lesion, the waiting period will be at least 14 days prior to the index procedure.
The subject is eligible for standard surgical repair, if necessary.
A subject who requires a coronary intervention should have it performed at least 7 days prior to the treatment of the target lesion.
Subject must provide written informed consent.
Subject must be willing to comply with the specified follow-up evaluation schedule.
Thrombophlebitis or deep venous thrombus, within the previous 30 days.
Receiving dialysis or immunosuppressant therapy within the previous 30 days.
Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
Stroke within the previous 90 days.
Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
Required stent placement via a popliteal approach.
Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation.
Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
Required stent placement within 1 cm of a previously deployed stent.
Subject required a coronary intervention, and the coronary intervention was done less than 7 days prior to or planned within 30 days after the treatment of the target lesion.
Known allergies to any of the following: aspirin, and all three of the following:clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), and prasugrel( Effient®); heparin, nitinol (nickel titanium); or contrast agent, that cannot be medically managed.
Presence of thrombus prior to crossing the lesion.
Known or suspected active infection at the time of the procedure.
Presence of an ipsilateral arterial artificial graft.
Use of cryoplasty, laser, or atherectomy devices in the target vessel at the time of index procedure.
Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurance.
Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
Subject has the following laboratory values:
a. platelet count less than 80,000/µL,
b. international normalized ratio (INR) greater than 1.5,
c. serum creatinine level greater than 2.0 mg/dL.
Subject requires general anesthesia for the procedure.
Subject is pregnant or plans to become pregnant during the study.
Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.