efficacy study of iliac stents to treat tasc a-b-c-d iliac artery lesions

Conditions: Peripheral Vascular Disease; Intermittent Claudication; Critical Limb Ischemia

Summary: the bravissimo trial wants to investigate in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol absolute pro (abbott vascular) and the balloon-expandable omnilink elite (abbott vascular) stent in tasc a\&b and tasc c\&d iliac lesions. a separate analysis of both patient populations will be performed and listed.


Eligibility criteria:
inclusion criteria: general * patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator) * patient presenting a score from 2 to 5 following rutherford classification * patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study * patient is \>18 years old * patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * patient is eligible for treatment with the absolute pro or omnilink elite (abbott vascular) angiographic * the target lesion is either a modified tasc-ii class a, b, c or d lesion with one of the listed specifications: * type a lesions * unilateral or bilateral stenoses of the common iliac artery * unilateral or bilateral single short (≤3 cm) stenosis of the external iliac artery * type b lesions * unilateral common iliac artery occlusion * single or multiple stenosis totaling 3-10 cm involving the external iliac artery not extending into the common femoral artery * unilateral external iliac artery occlusion not involving the origins of internal iliac artery or common iliac artery * type c lesions * bilateral common iliac artery occlusions * bilateral external iliac artery stenoses 3-10 cm long not extending into the common femoral artery * unilateral external iliac artery stenosis extending into the common femoral artery * unilateral external iliac artery occlusion that involves the origins of the internal iliac and/or common femoral artery * heavily calcified unilateral external iliac artery occlusion with or without involvement of origins of the internal iliac and/or common femoral artery * type d lesions * unilateral occlusions of both common iliac and external iliac artery * diffuse disease involving the aorta and both iliac arteries requiring treatment * diffuse multiple stenoses involving the unilateral common iliac, external iliac and common femoral artery * bilateral occlusions of external iliac artery * the target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation * there is angiographic evidence of a patent common an deep femoral artery exclusion criteria: * the target lesion is either a modified tasc-ii class b or d lesion with aortic lesion involvement: * type b lesions * short (≤3 cm) stenosis of infrarenal aorta * type d lesions * infra-renal aortoiliac occlusion * iliac stenoses in patients with an abdominal aortic aneurysm (aaa) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery * presence of aneurysm at the level of the iliac arteries * previously implanted stent(s) at the same lesion site * reference segment diameter is not suitable for available stent design * untreatable lesion located at the distal outflow arteries * use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure * patients refusing treatment * patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site * perforation at the angioplasty site evidenced by extravasation of contrast medium * patients with a history of prior life-threatening contrast medium reaction * patients with known hypersensitivity to nickel-titanium * patients with uncorrected bleeding disorders * female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * life expectancy of less than twelve months * any planned surgical intervention/procedure within 30 days of the study procedure * any patient considered to be hemodynamically unstable at onset of procedure * patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

Keywords: peripheral vascular disease intermittent claudication critical limb ischemia tasc a tasc b tasc c tasc d balloon-expandable stent self-expanding stent tasc