Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions (BELSTREAM)

This is an interventional treatment trial for Peripheral Arterial Disease Read More

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