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Table 2 Inclusion criteria and exclusion criteria

From: Comparison of BARD®LIFESTREAM™ covered balloon-expandable stent versus GORE® VIABAHN™ covered self-expandable stent in treatment of aortoiliac obstructive disease: study protocol for a prospective randomized controlled trial (NEONATAL trial)

Inclusion criteria

Exclusion criteria

The participants meeting the following criteria will be included:

(1) The subject is a male or non-pregnant (or no plan to become pregnant during study) female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.

(2) Symptomatic peripheral artery disease with moderate to severe claudication (Rutherford score of 2 to 3); chronic CLI with resting ischemic pain (Rutherford score of 4); chronic CLI with ischemic ulcers (Rutherford score of 5 to 6).

(3) Subjects diagnosed with aortoiliac obstructive disease (Trans-Atlantic Inter-Society Consensus, TASC II, TASC II A-D).

(4) The target lesion(s) can be successfully crossed with a guide wire and pre-dilated with an appropriately sized percutaneous endovascular angioplasty (PTA) balloon.

(5) The subject provides informed consent using an informed consent form (ICF) that is reviewed and approved by the Ethics Committee (EC).

The participants meeting the following criteria will be excluded:

(1) The subject is asymptomatic, has mild claudication described as Rutherford Category 0 (asymptomatic) or 1 (mild claudication).

(2) The subject has a vascular graft previously implanted in the native iliac vessel.

(3) The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion(s) or subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery.

(4) The subject has a serum creatinine ≥ 2.5 mg/dl or is currently on dialysis.

(5) The subject has a known uncorrectable bleeding diathesis or active coagulopathy (platelet count< 80,000/μL).

(6) The subject has intolerance to the antiplatelet, anticoagulant, or thrombolytic medications.

(7) The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE or contrast media.

(8) The subject suffered a stroke, or transient ischemic attack (TIA) within 3 months prior to the procedure.