New stent shows promise for Hard-to-Treat leg artery disease

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General inclusion criteria: * Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions. * 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 4 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 Lifestream Peripheral Stent Graft System (Bard) Angiographic inclusion criteria * The target lesion is either a modified TASC-II class C or D lesion with one of the listed specifications: * Type C lesions * Bilateral Common Iliac Artery occlusions * Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery * Type D lesions * Unilateral occlusions of both Common Iliac and External Iliac Artery * Diffuse disease involving the aorta bifurcation * Bilateral occlusions of External Iliac Artery * The target lesion has angiographic evidence of stenosis or restenosis post percutaneous transluminal angioplasty (PTA) \> 50% or occlusion which can be passed with standard guidewire manipulation * There is angiographic evidence of a patent Common and Deep Femoral Artery Exclusion criteria: * PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter) * Presence of an aneurysm immediately adjacent to the site of stent graft implantation * Lesions in or adjacent to essential collaterals(s) * Lesions in locations subject to external compression * Heavily calcified lesions resistant to PTA * Patients with diffuse distal disease resulting in poor stent graft outflow * Patients with a history of coagulation disorders * Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy * Fresh thrombus formation * Patients with known hypersensitivity to the stent material (L605) and or polytetrafluroethylene (PTFE) * The target lesion is either a modified TASC-II class C or D lesion with aortic or common femoral lesion involvement: * Type C lesions * 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 involvement of the Common Femoral Artery * 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 * Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery * Previously implanted stent(s) at the same lesion site * Reference segment diameter is not suitable for the available stent graft design * Untreatable lesion located at the distal outflow arteries * Use of alternative therapy (e.g. atherectomy, cutting balloon, drug coated balloon (DCB), laser, radiation therapy) as part of the index procedure * Patients refusing treatment * Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * Perforation at the angioplasty site evidenced by extravasation of contrast medium * Patients with a history of prior life-threatening contrast medium reaction * 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