Belgian Physician-initiated Trial Investigating the LifeStream Peripheral Stent Graft System for the Treatment of Complex TASC C and D Iliac Lesions
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: ID3 Medical

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NCT03349996   Unique Protocol ID: ID3-20170704 
 
PROTOCOL SYNOPSIS: BELSTREAM study 
 
Title 
Belgian Physician-Initiated Trial Investigating the Lifestream Peripheral Stent Graft 
System for the treatment of complex TASC C and D iliac lesions 
Objective 
The objective of this clinical investigation is to evaluate, in a controlled setting, the 
long-term (up to 60 months) safety and efficacy of the Lifestream Peripheral Stent 
Graft System (Bard) in clinical settings post CE-certification when used according to 
the indications of the IFU. 
Methodology 
Prospective, multi-center, physician-sponsored clinical study 
Enrollment 
70 subjects 
Primary Endpoint 
Efficacy 
endpoint 
 
 
 
 
 
 
Safety 
endpoint  
The primary endpoint of the study is primary patency at 12 months ,      
defined as a 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) within 
12 months. TLR is defined as a repeated intervention to maintain or re-
establish patency within the region of the treated arterial vessel plus 
5mm proximal and distal to the treated lesion edge. 
 
The primary safety endpoint of the study is the freedom of 
periprocedural Serious Adverse Events (SAEs), defined according to ISO 
14155:2011 as any clinical event that is fatal, life-threatening, or judged 
to be severe by the investigator; resulted in persistent or significant 
disability; necessitated surgical or percutaneous intervention; or 
required prolonged hospitalization. 
Secondary Endpoint 
1. 
Primary patency rate at 1-, 6-, 24-, 36-, 48- and 60 month follow-up. 
Patients that present without a hemodynamically significant stenosis at 
the target area on duplex ultrasound (>50%, systolic velocity ratio 
greater than 2.5) and without prior TLR are defined as being primary 
patent at the given follow-up. 
2. 
Stent graft occlusion rate at pre-discharge, 1-, 6-, 12-, 24-, 36-, 48-, and 
60-month follow-up. 
3. 
Ankle Brachial Index (ABI) at 1-, 6-, 12-, 24-, 36-, 48- and 60 month follow-
up compared with the baseline ABI. 
4. 
Amputation rate at 1-, 6-, 12-, 24-, 36-, 48- and 60 month follow-up, 
defined as any amputation above the knee. 
5. 
Technical success, defined as the ability to achieve final residual 
angiographic stenosis no greater than 30%. 
6. 
Clinical success at follow-up is defined as an improvement of Rutherford 
classification at 1-, 6-, 12-, 24-, 36-, 48- and 60 -month follow-up of one 
class or more as compared to the pre-procedure Rutherford 
classification. 
Inclusion Criteria 
General inclusion criteria 
1. 
Corresponding to the CE-mark indications/contra-indications and 
according to the current medical guidelines for minimally invasive 
peripheral interventions. 
2. 
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) 
3. 
Patient presenting a score from 2 to 4 following Rutherford classification  
4. 
Patient is willing to comply with specified follow-up evaluations at the 
specified times for the duration of the study  
5. 
Patient is >18 years old 

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6. 
Patient (or their legal representative) understands the nature of the 
procedure and provides written informed consent, prior to enrolment in 
the study  
7. 
Patient is eligible for treatment with the Lifestream Peripheral Stent Graft 
System (Bard) 
 
Angiographic inclusion criteria 
1. 
The target lesion is either a modified TASC-II class C or D lesion with one 
of the listed specifications: 
o 
Type C lesions 
• 
Bilateral Common Iliac Artery occlusions 
• 
Bilateral External Iliac Artery stenoses 3–10 cm 
long not extending into the Common Femoral 
Artery 
o 
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 
2. 
The target lesion has angiographic evidence of stenosis or restenosis  post 
PTA >50% or occlusion which can be passed with standard guidewire 
manipulation 
3. 
There is angiographic evidence of a patent Common and Deep Femoral 
Artery 
Exclusion criteria 
1. 
PTA is technically not possible (not feasible to access the lesion or a 
defect with the guidewire or balloon catheter) 
2. 
Presence of an aneurysm immediately adjacent to the site of stent graft 
implantation 
3. 
Lesions in or adjacent to essential collaterals(s) 
4. 
Lesions in locations subject to external compression 
5. 
Heavily calcified lesions resistant to PTA 
6. 
Patients with diffuse distal disease resulting in poor stent graft outflow 
7. 
Patients with a history of coagulation disorders 
8. 
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 
9. 
Fresh thrombus formation 
10. 
Patients with known hypersensitivity to the stent material (L605) and/or 
PTFE 
11. 
The target lesion is either a modified TASC-II class C or D lesion with aortic 
or common femoral lesion involvement: 
o 
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 the involvement of the 
Common Femoral Artery 
o 
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 

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other lesions requiring open aortic or iliac 
surgery 
• 
Diffuse multiple stenoses involving the 
unilateral Common Iliac, External Iliac and 
Common Femoral Artery 
12. 
Previously implanted stent(s) at the same lesion site 
13. 
Reference segment diameter is not suitable for the available stent graft 
design 
14. 
Untreatable lesion located at the distal outflow arteries 
15. 
Use of alternative therapy (e.g. atherectomy, cutting balloon, DCB, laser, 
radiation therapy) as part of the index procedure 
16. 
Patients refusing treatment 
17. 
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic 
drugs are contraindicated 
18. 
Patients who exhibit persistent acute intraluminal thrombus of the 
proposed lesion site 
19. 
Perforation at the angioplasty site evidenced by extravasation of contrast 
medium 
20. 
Patients with a history of prior life-threatening contrast medium reaction 
21. 
Patients with uncorrected bleeding disorders 
22. 
Female patient with child bearing potential not taking adequate 
contraceptives or currently breastfeeding 
23. 
Life expectancy of less than twelve months 
24. 
Any planned surgical intervention/procedure within 30 days of the study 
procedure 
25. 
Any patient considered to be hemodynamically unstable at onset of 
procedure 
P.I. 
Dr. Peter Goverde, ZNA Campus Stuivenberg, Antwerp, Belgium 
Study conduct 
The study will be conducted in accordance with the Declaration of Helsinki and ISO 
14155:2011, and comply with requirements regarding Ethics Committees and any 
other applicable regulations 
Participating sites 
• 
A.Z. Groeninge, Kortrijk, Belgium: Dr. Lerut 
• 
A.Z. Sint-Blasius, Dendermonde, Belgium: Dr. Deloose 
• 
Imelda Hospital, Bonheiden, Belgium: Dr. Verbist 
• 
O.L.V. Hospital, Aalst, Belgium: Dr. Maene 
• 
R.Z. H.H., Tienen, Belgium: Dr. Keirse 
• 
Z.O.L., Genk, Belgium: Dr. Lansink 
• 
Z.N.A. Stuivenberg, Antwerpen, Belgium: Dr. Goverde 
 
 
 

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Table 1. Study Investigations 
 
Time  
 
Tests and Procedures 
Pre-Procedure 
(up to 24 hours before procedure,    
       unless otherwise noted.) 
1. 
2. 
3. 
4. 
Medical History 
Medication Registration 
Physical Exam 
Rutherford Categorization and ABI 
Procedure 
1. 
2. 
3. 
4. 
Angiography, pre–procedure  
Study inclusion 
Intervention  
Rutherford Categorization and ABI 
One day Post-Procedure  
1. 
2. 
3. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
One month Follow-up  
 
   ( 7 days) 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
Six month Follow-up 
    ( 30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
One year Follow-up 
    ( 30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
Two year Follow-up 
    (730  30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
Three year Follow-up 
    (1095  30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
Four year Follow-up 
    (1460  30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
Five year Follow-up 
    (1825  30 days) 
 
1. 
2. 
3. 
4. 
Medication Registration 
Physical Examination 
Rutherford Categorization and ABI 
Colour Flow Doppler Ultrasound 
 
 
 
 
 
• 
Statistical Analysis Plan (SAP)  
Descriptive data summaries will be used to present and summarize the collected data. For 
categorical variables (e.g. Gender) frequency distributions and cross tabulations will be given. For 
numeric variables (e.g. Patient age) minimum, maximum, mean, median and standard deviation will 
be calculated. For all variables a 95% confidence interval for the relevant parameters of the 
underlying distribution will be calculated. For all time-dependent events life-tables will be calculated 
using the Kaplan Meier estimate method, for a period starting on the date of the procedure up to 
and including the 60-month follow-up visit. Stratification to pre-procedural risk factors, Rutherford 
and lesion criteria will be performed and the log rank test will be used to compare between the 
different outcomes, associated p-values < 0.05 are defined as significant.