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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03349996
• Date of registration: 17/11/2017
• Prospective Registration: No
• Primary sponsor: ID3 Medical
• Public title: Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions BELSTREAM
• Scientific title: Belgian Physician-initiated Trial Investigating the LifeStream Peripheral Stent Graft System for the Treatment of Complex TASC C and D Iliac Lesions
• Date of first enrolment: October 31, 2017
• Target sample size: 70
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03349996
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Koen Deloose, MD
• Affiliation: ID3 Medical

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Intervention(s)

Device: LifeStream Peripheral Stent Graft System

Primary Outcome(s)

Primary patency at 12 months [Time Frame: 12 months]

Freedom from periprocedural Serious Adverse events (SAEs) [Time Frame: During index procedure]

Secondary Outcome(s)

Amputation rate [Time Frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure]

Clinical success [Time Frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure]

Technical success [Time Frame: Index procedure]

Ankle-Brachial index (ABI) [Time Frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedure]

Primary patency at 1 ,6 ,24 ,36 ,48 and 60- months post procedure [Time Frame: 1 ,6 ,24 ,36 ,48 and 60-months post-procedure]

Stent graft occlusion rate [Time Frame: Pre-discharge,1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up]

Secondary ID(s)

ID3-20170704

Source(s) of Monetary Support

Please refer to primary and secondary sponsors