Trial Outcomes & Findings for Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions (NCT NCT03349996)
NCT ID: NCT03349996
Last Updated: 2026-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
Before the end of the 12 month follow-up window
Results posted on
2026-03-05
Participant Flow
Participant milestones
| Measure |
LifeStream Peripheral Stent Graft System
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
LifeStream Peripheral Stent Graft System
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Death
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 8 • n=70 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=70 Participants
|
|
Region of Enrollment
Belgium
|
70 participants
n=70 Participants
|
|
Nicotine abuse
|
65 Participants
n=70 Participants
|
|
Hypertension
|
52 Participants
n=70 Participants
|
|
Hypercholesterolemia
|
46 Participants
n=70 Participants
|
|
Previous arterial intervention
|
15 Participants
n=70 Participants
|
|
Previous coronary intervention
|
17 Participants
n=70 Participants
|
|
Obesity
|
17 Participants
n=70 Participants
|
PRIMARY outcome
Timeframe: Before the end of the 12 month follow-up windowPopulation: Three patients experienced loss of primary patency 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.
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Primary Patency Rate Before Completion of the 12-month Follow-up Period.
|
3 participants
|
PRIMARY outcome
Timeframe: During the index procedure and within 24 hours post-procedurePeriprocedural SAEs as defined according to the International Organization for Standardization guidelines (ISO) 14155:2011
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Number of Periprocedural Serious Adverse Events (SAEs)
|
4 Serious Adverse events
|
SECONDARY outcome
Timeframe: 1 ,6 ,24 ,36 ,48 and 60-months post-procedurePopulation: Cumulative patency loss up to 60 months.
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)
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 6 month
|
1 Participants
|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 24 month
|
4 Participants
|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 1 month
|
0 Participants
|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 36 month
|
4 Participants
|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 48 month
|
4 Participants
|
|
Primary Patency at 1 ,6 ,24 ,36 ,48 and 60- Months Post Procedure
Primary patency lost at 60 month
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-upPopulation: Cumulative stent graft occlusions up to 60 months.
Occlusion of the stent graft system
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Stent Graft Occlusion Rate
Stent occlusion at 60 month
|
5 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 1 month
|
0 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 6 month
|
1 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 12 month
|
2 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 24 month
|
2 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 36 month
|
2 Participants
|
|
Stent Graft Occlusion Rate
Stent occlusion at 48 month
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedurePopulation: Evolution of ABI relative baseline ABI
ABI at follow-up compared with the baseline ABI
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=62 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Ankle-Brachial Index (ABI)
1 month post-procedure · Increased ABI compared to baseline
|
56 Participants
|
|
Ankle-Brachial Index (ABI)
1 month post-procedure · Same ABI as baseline
|
2 Participants
|
|
Ankle-Brachial Index (ABI)
1 month post-procedure · Decreased ABI compared to baseline
|
4 Participants
|
|
Ankle-Brachial Index (ABI)
6 month post-procedure · Increased ABI compared to baseline
|
50 Participants
|
|
Ankle-Brachial Index (ABI)
6 month post-procedure · Same ABI as baseline
|
1 Participants
|
|
Ankle-Brachial Index (ABI)
6 month post-procedure · Decreased ABI compared to baseline
|
0 Participants
|
|
Ankle-Brachial Index (ABI)
12 month post-procedure · Increased ABI compared to baseline
|
43 Participants
|
|
Ankle-Brachial Index (ABI)
60 month post-procedure · Increased ABI compared to baseline
|
30 Participants
|
|
Ankle-Brachial Index (ABI)
60 month post-procedure · Same ABI as baseline
|
1 Participants
|
|
Ankle-Brachial Index (ABI)
60 month post-procedure · Decreased ABI compared to baseline
|
3 Participants
|
|
Ankle-Brachial Index (ABI)
12 month post-procedure · Same ABI as baseline
|
0 Participants
|
|
Ankle-Brachial Index (ABI)
12 month post-procedure · Decreased ABI compared to baseline
|
3 Participants
|
|
Ankle-Brachial Index (ABI)
36 month post-procedure · Increased ABI compared to baseline
|
20 Participants
|
|
Ankle-Brachial Index (ABI)
36 month post-procedure · Same ABI as baseline
|
0 Participants
|
|
Ankle-Brachial Index (ABI)
36 month post-procedure · Decreased ABI compared to baseline
|
1 Participants
|
|
Ankle-Brachial Index (ABI)
48 month post-procedure · Increased ABI compared to baseline
|
34 Participants
|
|
Ankle-Brachial Index (ABI)
48 month post-procedure · Same ABI as baseline
|
1 Participants
|
|
Ankle-Brachial Index (ABI)
48 month post-procedure · Decreased ABI compared to baseline
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedureAny amputation above the knee
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Amputation Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Index procedureAbility to achieve final residual angiographic stenosis no greater than 30%
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=70 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Number of Participants With Technical Success
|
70 Participants
|
SECONDARY outcome
Timeframe: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedurePopulation: Rutherford classification compared to the baseline measurement
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.
Outcome measures
| Measure |
LifeStream Peripheral Stent Graft System
n=69 Participants
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Clinical Success
12 month post-procedure · Decreased RCC compared to baseline
|
54 Participants
|
|
Clinical Success
12 month post-procedure · Increased RCC compared to baseline
|
0 Participants
|
|
Clinical Success
60 month post-procedure · Decreased RCC compared to baseline
|
38 Participants
|
|
Clinical Success
1 month post-procedure · Decreased RCC compared to baseline
|
67 Participants
|
|
Clinical Success
1 month post-procedure · Same RCC compared to baseline
|
2 Participants
|
|
Clinical Success
1 month post-procedure · Increased RCC compared to baseline
|
0 Participants
|
|
Clinical Success
6 month post-procedure · Decreased RCC compared to baseline
|
62 Participants
|
|
Clinical Success
6 month post-procedure · Same RCC compared to baseline
|
0 Participants
|
|
Clinical Success
6 month post-procedure · Increased RCC compared to baseline
|
0 Participants
|
|
Clinical Success
12 month post-procedure · Same RCC compared to baseline
|
4 Participants
|
|
Clinical Success
36 month post-procedure · Decreased RCC compared to baseline
|
25 Participants
|
|
Clinical Success
36 month post-procedure · Same RCC compared to baseline
|
0 Participants
|
|
Clinical Success
36 month post-procedure · Increased RCC compared to baseline
|
0 Participants
|
|
Clinical Success
48 month post-procedure · Decreased RCC compared to baseline
|
40 Participants
|
|
Clinical Success
48 month post-procedure · Same RCC compared to baseline
|
1 Participants
|
|
Clinical Success
48 month post-procedure · Increased RCC compared to baseline
|
0 Participants
|
|
Clinical Success
60 month post-procedure · Same RCC compared to baseline
|
2 Participants
|
|
Clinical Success
60 month post-procedure · Increased RCC compared to baseline
|
1 Participants
|
Adverse Events
LifeStream Peripheral Stent Graft System
Serious events: 38 serious events
Other events: 28 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
LifeStream Peripheral Stent Graft System
n=70 participants at risk
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Blood and lymphatic system disorders
Severe anemia causing dyspnea and malaise
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Cardiac disorders
heart failure
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Eye disorders
Cataract
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Fatal postoperative paralytic ileus with abdominal compartment syndrome
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Positive immunochemical fecal occult blood test
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colonic polyps
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
gastroscopy and colonoscopy
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Uncomplicated diverticulitis
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
General disorders
Fatal condition aggravated
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Infections and infestations
Acute on chronic renal insufficiency
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Infections and infestations
Fatal COVID-19 respiratory failure
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Right hip fracture
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Cutting wound right wrist
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Repeated falls, cognitive decline, aspiration pneumonia, DM2, hyperthyroidism, sinus bradycardia
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chronic lower back pain with bilateral lumboischialgia and lower limb weakness
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cartilage damage left knee
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fatal metastatic cancer
|
4.3%
3/70 • Number of events 3 • 5 years
|
|
Nervous system disorders
Fatal intracranial haemorrhage with cardiorespiratory arrest
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Brain metastases resulting in epileptic insult
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Ataxia arms and legs, instability, ethylabusus
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Phatic disorder on hypoglycemia
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary tract infection and nephrolithiasis
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
2.9%
2/70 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Infections and infestations
HPV-related high-grade PIN
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Vascular disorders
Claudication
|
1.4%
1/70 • Number of events 2 • 5 years
|
|
General disorders
Fatal hypovolemic shock secondary to dehydration and renal failure
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Vascular disorders
Fatal thromboembolic event
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Perforation of right iliac artery
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Vascular disorders
Perforation of right iliac artery
|
18.6%
13/70 • Number of events 14 • 5 years
|
Other adverse events
| Measure |
LifeStream Peripheral Stent Graft System
n=70 participants at risk
Patients treated with the LifeStream Peripheral Stent Graft System
LifeStream Peripheral Stent Graft System: Patients will be treated with the LifeStream Peripheral Stent Graft System
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Cardiac disorders
Retrosternal pain
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Eye disorders
Cataract development
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Bleeding wound of the lower leg
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Investigations
Elevated PSA (asymptomatic)
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
7.1%
5/70 • Number of events 6 • 5 years
|
|
Nervous system disorders
Neurogenic tingling in ankles
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Polyneuropathy
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Nervous system disorders
Occipital headache
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Sudden dizziness causing fall; no acute intracranial trauma
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Nervous system disorders
Small lacunar cerebral infarcts
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Acute ethanol intoxication
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial irritation after accidental hydrochloric acid inhalation
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Wound inflammation
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Balloon rupture during predilatation
|
1.4%
1/70 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
arterial dissection
|
2.9%
2/70 • Number of events 2 • 5 years
|
|
Vascular disorders
Peripheral arterial stenosis
|
5.7%
4/70 • Number of events 4 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place