CompletedNot Applicable

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

Belgium70 participantsStarted 2017-10-31

Plain-language summary

The BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of 70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the LifeStream Peripheral Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 ,36 ,48 and 60-month post-procedure. .The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1 ,6 ,24 ,36 ,48 and 60 month, stent graft occlusion rate at pre-discharge, 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, anke-brachial index (ABI) at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, amputation rate at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, technical success and clinical success at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Patency Rate Before Completion of the 12-month Follow-up Period.

Timeframe: Before the end of the 12 month follow-up window

Number of Periprocedural Serious Adverse Events (SAEs)

Timeframe: During the index procedure and within 24 hours post-procedure

Trial details

NCT IDNCT03349996

SponsorID3 Medical

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-21

Results submitted2026-01-21

View on ClinicalTrials.gov More Peripheral Arterial Disease trials