In This SectionTexas Health Research & Education Institute
Disease or Condition
Heart / Stent
Evaluation of self-expanding stent system in the iliac artery (Heart / Stent)
The primary objective of this study is to evaluate the safety and efficacy of the Absolute Pro self-expanding stent system in patients with a narrowing of the iliac artery in the leg. A stent is a small metal mesh tube that is placed inside a narrowed artery to hold it open.
Subject must be at least 18 and < 90 years of age.
Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
History of symptomatic claudication (Rutherford BeckerClinical Category 2-3) or ischemic rest pain (RutherfordBecker Clinical Category 4).
Female subjects of childbearing potential must have had a negative pregnancy test (serum HCG) within 14 days before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.
Angiographic Inclusion Criteria:
1. Up to two bilateral de novo or restenotic [defined as nonstented or not previously treated with atherectomy, surgery, or laser] lesions of the native common iliac artery and/or native external iliac artery may be treated (one per side).
2. Common iliac artery lesion visually estimated to be ≥ 50% stenosis and ≤ 100% stenosis (total occlusion)
3. External iliac artery lesion visually estimated to be ≥ 50% stenosis and ≤ 99% stenosis.
4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 90mm (Absolute Pro).
5. Lesion length for total occlusion of the common iliac artery visually estimated to be = 40 mm.
6. Target vessel reference diameter visually estimated to be ≥ 3.6 mm and ≤ 9.1 mm (Absolute Pro).
7. Patent superficial femoral and popliteal arteries (< 50%stenosis) and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography.
Subject is unable to walk.
Subject has had recent major surgery (last 3 months) e.g.,abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
Subject has elevated serum creatinine > 2.5 mg/dl.
Subject has had a myocardial infarction (MI) within the previous 30 days.
Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subject’s ability to walk.
Subject has unstable angina defined as rest angina with ECG changes.
Subject has a groin infection, or an acute systemic infection that is currently under treatment.
Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
Subject requires any planned procedure that would necessitate the discontinuation of clopidogrel or ticlopidine following the procedure. If the subject is enrolled into the trial and then subsequently requires a medical procedure which would necessitate the discontinuation of these medications, then the subject is to resume protocol required medications as soon as possible after the medical procedure.
Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with limited lifeexpectancy (i.e., less than 2 years).
Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints. (Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies.)
Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
Subject has known hypersensitivity or contraindication to nickel, titanium, platinum, or standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which
cannot be adequately pre-treated with medication.
Subject has known allergy or contraindication to clopidogrel (Plavix) or aspirin and is unable to tolerate ticlopidine (Ticlid).
Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
Angiographic Exclusion Criteria:
1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
3. Target lesion is within or adjacent to an aneurysm.
4. Lesion is located within or beyond a bypass graft.
5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
7. Lesion extends beyond the inguinal ligament.
8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
10. Subject is without patent superficial femoral and popliteal arteries (<50% stenosis) and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography.