Trial Outcomes & Findings for A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms (NCT NCT00646048)
NCT ID: NCT00646048
Last Updated: 2011-01-28
Results Overview
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
1 month
Results posted on
2011-01-28
Participant Flow
Participant milestones
| Measure |
TriVascular Stent Graft
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
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Overall Study
STARTED
|
43
|
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Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
TriVascular Stent Graft
n=43 Participants
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
|
Age Continuous
|
73.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthDevice related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
Outcome measures
| Measure |
TriVascular Stent Graft
n=43 Participants
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
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Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
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36 Participants
|
PRIMARY outcome
Timeframe: 1 monthA Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.
Outcome measures
| Measure |
TriVascular Stent Graft
n=43 Participants
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
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Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
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0 Participants
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SECONDARY outcome
Timeframe: Post procedureTechnical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.
Outcome measures
| Measure |
TriVascular Stent Graft
n=43 Participants
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
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Number of Participants Who Achieve Technical Success of the Stent Graft System.
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42 Participants
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Adverse Events
TriVascular Stent Graft
Serious events: 35 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TriVascular Stent Graft
n=43 participants at risk
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
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|---|---|
|
Metabolism and nutrition disorders
Fluid overload
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Angina pectoris
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Aortic valve stenosis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Cardiac disorder
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure congestive
|
9.3%
4/43 • Number of events 7 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Cardiomyopathy
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Cardiopulmonary failure
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Cardiac disorders
Ventricular hypokinesia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Endocrine disorders
Goitre
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
General disorders
Asthenia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
General disorders
Catheter site related reaction
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
General disorders
Death
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
General disorders
Ulcer
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Bacteriuria
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Catheter site cellulitis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Catheter site infection
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Cellulitis
|
2.3%
1/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Endocarditis bacteraemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Gangrene
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Infection
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Lobar pneumonia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Pneumonia
|
11.6%
5/43 • Number of events 5 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Stent related infection
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Device breakage
|
16.3%
7/43 • Number of events 7 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Device failure
|
14.0%
6/43 • Number of events 7 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Device migration
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Device occlusion
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
2.3%
1/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
18.6%
8/43 • Number of events 8 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
18.6%
8/43 • Number of events 11 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Investigations
Haemoglobin decreased
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Investigations
Laboratory test abnormal
|
2.3%
1/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Nervous system disorders
Syncope
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Nervous system disorders
Transient ischaemic attack
|
4.7%
2/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Psychiatric disorders
Mental status changes
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
7.0%
3/43 • Number of events 4 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.3%
1/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Surgical and medical procedures
Aortic surgery
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Surgical and medical procedures
Coronary artery bypass
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Aorto-duodenal fistula
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Arterial thrombosis limb
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Embolism
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Haemorrahage
|
4.7%
2/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Hypertension
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Hypotension
|
11.6%
5/43 • Number of events 5 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Iliac artery occlusion
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Iliac artery thrombosis
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Intermittent claudication
|
4.7%
2/43 • Number of events 2 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
2.3%
1/43 • Number of events 1 • Baseline through 5 year follow-up.
|
Other adverse events
| Measure |
TriVascular Stent Graft
n=43 participants at risk
This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.
|
|---|---|
|
General disorders
Catheter site haematoma
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
General disorders
Catheter site related reaction
|
7.0%
3/43 • Number of events 3 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Device breakage
|
27.9%
12/43 • Number of events 12 • Baseline through 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
7.0%
3/43 • Number of events 4 • Baseline through 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 4 • Baseline through 5 year follow-up.
|
|
Vascular disorders
Intermittent claudication
|
18.6%
8/43 • Number of events 8 • Baseline through 5 year follow-up.
|
Additional Information
Colleen Holthe, Clinical Project Manager
Boston Scientific
Phone: 651-581-4632
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER