Peripheral Arterial DiseaseBELSTREAMNCT03349996
Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions
A study testing LifeStream Peripheral Stent Graft System in people with Peripheral Arterial Disease, run by ID3 Medical at 7 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- LifeStream Peripheral Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesBelgium
- Study dates
- 31 Oct 2017to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 32Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
O.L.V. Hospital
Aalst, 9300
Z.N.A.
Antwerp, 2060
Imelda Hospital
Bonheiden, 2820
A.Z. Sint-Blasius
Dendermonde, 9200
Z.O.L.
Genk, 3600
Az Groeninge
Kortrijk, 8500
R.Z. Heilig Hart
Tienen, 3300
About this study
Official title: Belgian Physician-initiated Trial Investigating the LifeStream Peripheral Stent Graft System for the Treatment of Complex TASC C and D Iliac Lesions
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.
Read the detailed description
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the LifeStream Peripheral Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC C and D iliac lesions.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. At the physician's discretion, the patient receives at least 1 LifeStream Peripheral Stent Graft System. Pre- and post-dilatation are according to the physician's discretion. No other adjunctive therapies (atherectomy, laser) are allowed. The complete iliac vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the stent/procedure. Patients will be invited for a follow-up visit at 1 ,6 ,12 ,24 ,36 ,48 and 60-months after the index procedure. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
- Conditions
- Peripheral Arterial Disease
- Being tested
- LifeStream Peripheral Stent Graft System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeStream Peripheral Stent Graft SystemDevice
Patients will be treated with the LifeStream Peripheral Stent Graft System
| Study group | Role | What they receive |
|---|---|---|
| LifeStream Peripheral Stent Graft System | Experimental | Patients treated with the LifeStream Peripheral Stent Graft System Receives: Device: LifeStream Peripheral Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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)
Measured: 1 ,6 ,24 ,36 ,48 and 60-months post-procedure
Stent Graft Occlusion Rate
Occlusion of the stent graft system
Measured: 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up
Ankle-Brachial Index (ABI)
ABI at follow-up compared with the baseline ABI
Measured: 1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedure
Amputation Rate
Any amputation above the knee
Measured: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
Number of Participants With Technical Success
Ability to achieve final residual angiographic stenosis no greater than 30%
Measured: Index procedure
Clinical Success
Rutherford Classification Category (0-6) was assessed according to established clinical criteria for peripheral artery disease. Categories range from 0 (asymptomatic) to 6 (severe tissue loss or gangrene). Classification was determined by the investigator based on symptoms and physical examination. Change from baseline was evaluated at each follow-up visit. Improvement was defined as a decrease of ≥1 Rutherford category compared with baseline.
Measured: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start31 Oct 2017
- Primary completion21 Oct 2020
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Study director, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349996
- Sponsor's protocol ID
- ID3-20170704
- Acronym
- BELSTREAM
- Status last verified
- Jan 2026
- First submitted
- 17 Nov 2017
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Physician-initiated Trial Investigating the LifeStream Peripheral Stent Graft System for the Treatment of Complex TASC C and D Iliac Lesions
- ClinicalTrials.gov ID
- NCT03349996
- Acronym / sponsor ID
- BELSTREAM / ID3-20170704
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the LifeStream Peripheral Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC C and D iliac lesions.
Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).
During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. At the physician's discretion, the patient receives at least 1 LifeStream Peripheral Stent Graft System. Pre- and post-dilatation are according to the physician's discretion. No other adjunctive therapies (atherectomy, laser) are allowed. The complete iliac vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.
The regular follow-ups are necessary to monitor the condition of the patient and the stent/procedure. Patients will be invited for a follow-up visit at 1 ,6 ,12 ,24 ,36 ,48 and 60-months after the index procedure. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LifeStream Peripheral Stent Graft System | Experimental | Device: LifeStream Peripheral Stent Graft SystemPatients treated with the LifeStream Peripheral Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeStream Peripheral Stent Graft SystemPatients will be treated with the LifeStream Peripheral Stent Graft System | Device | LifeStream Peripheral Stent Graft System |
Primary outcome
Primary Patency Rate Before Completion of the 12-month Follow-up Period.
Time frame: Before the end of the 12 month follow-up window
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.
Number of Periprocedural Serious Adverse Events (SAEs)
Time frame: During the index procedure and within 24 hours post-procedure
Periprocedural SAEs as defined according to the International Organization for Standardization guidelines (ISO) 14155:2011
6 secondary outcomes
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: 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up
Ankle-Brachial Index (ABI)
Time frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedure
Amputation Rate
Time frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
Number of Participants With Technical Success
Time frame: Index procedure
Clinical Success
Time frame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD study director
ID3 Medical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeStream Peripheral Stent Graft System in people with Peripheral Arterial Disease, run by ID3 Medical at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate Before Completion of the 12-month Follow-up Period. (time frame: Before the end of the 12 month follow-up window). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.