In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Stent
Evaluation of the GORE ®TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal (Heart/Stent)
The primary objective of the study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of new and restenotic atherosclerotic lesions in the superficial femoral (SFA) and proximal popliteal arteries (PPA) in patients experiencing pain when they walk and having lesions =/< 24 cm. in length.
Rutherford Class 2-4.
Abnormal ankle-brachial index (ABI=/<0.9). If ABI is not measurable due to medial calcinosis, an abnormal toe brachial index (TBI=/<0.7) may be substituted.
At least 21 years of age.
Subject or legal representative willing to give written informed consent.
Reasonable expectation of survival of at least 12 months after the procedure.
Male, infertile female, or female practicing an effective method of prevention of pregnancy.
Ability to participate in follow-up visits as required by the protocol.
Meets angiographic inclusion criteria. Criteria used to establish that the patient is a candidate for treatment by stenting within the limits of this protocol are assessed angiographically at the time of stent implantation. To be eligible for inclusion in the study, patients must meet all of the following angiographic criteria:
a. One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be =/< 24 cm, with one or more regions of focal luminal narrowing =/>50%. The lesion must be located in the region beginning approximately 1 cm below the origin of the profunda femoris artery and ending approximately 1 cm above the intercondylar notch.
b. Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated
c. Angiographic evidence of at least one patent tibial artery (<50% stenosis angiographically)
from the origin to the ankle that does not require planned intervention at the time of the
procedure or with 12 months of enrollment.
d. Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
e. Lesion has been pre-dilated before stent deployment.
Prior enrollment in this study.
Vascular access/catheterization in the target leg within 30 days of study enrollment. [NOTE: Diagnostic catheterization done for the purposes of planning and scheduling the interventional procedure is allowed.]
Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
Flow-limiting aortoiliac disease. [NOTE: Patients receiving successful treatment of iliac disease during the same procedure may enroll in the study if all other inclusion/exclusion criteria have been met.]
Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented.
Arterial aneurysm in the target leg.
Co-morbid conditions which would preclude compliance with study protocol.
Obstructive or occlusive non-atherosclerotic disease.
Creatinine greater than 2.5 mg/dl.
Amputation above the metatarsals, resulting from vascular disease, in the target leg.
Septicemia or uncontrolled infection.
Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive PF4 antibody assay.
Abnormal platelet levels, i.e., platelet count at baseline less than 80,000/µL.
History of coagulopathy.
Participation in any other clinical research study that might confound the endpoints of this study.
Any other factor identified by the Investigator that would disqualify the prospective subject from participation in the study.