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

NCT03349996 | Completed Results

• 1 other identifier: ID3-20170704
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

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

  Target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio greater than 2.5) and with freedom from Target Lesion Revascularization (TLR) before completion of the 12-month follow-up period.

  Before the end of the 12 month follow-up window

• Number of Periprocedural Serious Adverse Events (SAEs)

  Periprocedural SAEs as defined according to the International Organization for Standardization guidelines (ISO) 14155:2011

  During the index procedure and within 24 hours post-procedure

Secondary Outcomes (6)

• Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure

  1 ,6 ,24 ,36 ,48 and 60-months post-procedure

• Stent Graft Occlusion Rate

  1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up

• Ankle-Brachial Index (ABI)

  1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedure

• Amputation Rate

  1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure

• Number of Participants With Technical Success

  Index procedure

Study Arms (1)

LifeStream Peripheral Stent Graft System

EXPERIMENTAL

Patients treated with the LifeStream Peripheral Stent Graft System

Device: LifeStream Peripheral Stent Graft System

Interventions

LifeStream Peripheral Stent Graft System DEVICE

Patients will be treated with the LifeStream Peripheral Stent Graft System

LifeStream Peripheral Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (7)

O.L.V. Hospital

Aalst, 9300, Belgium

Location

Z.N.A.

Antwerp, 2060, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

Z.O.L.

Genk, 3600, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

R.Z. Heilig Hart

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Clinical Research Professional
• Organization: iD3 Medical

office@id3medical.com

+32 (0)52252745

Study Officials

• Koen Deloose, MD

  ID3 Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: October 31, 2017
• Primary Completion: October 21, 2020
• Study Completion: January 15, 2025
• Last Updated: March 5, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Locations

BE (7)