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This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | This arm is for patient that receive the TriVascular Stent-Graft System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriVascular Stent-Graft System | Device | TriVascular Stent-Graft System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. | 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. | 1 month |
| Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). | A 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve Technical Success of the Stent Graft System. | Technical 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Grady, PhD | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor UCLA Medical Center | Torrance | California | 90509 | United States | ||
| Georgetown University Pasquerilla Healthcare |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Post procedure |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| University of Florida - Shands Hospital | Gainesville | Florida | 32610 | United States |
| Miami Cardiac & Vascular Institute Baptist Hospital | Miami | Florida | 33176 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure. | 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. | Posted | Number | Participants | 1 month |
|
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| |||||||||||||||||||||||||||
| Primary | Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT). | A 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. | Posted | Number | Participants | 1 month |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieve Technical Success of the Stent Graft System. | Technical 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. | Posted | Number | Participants | Post procedure |
|
|
Baseline through 5 year follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 35 | 43 | 33 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Death | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Ulcer | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Endocarditis bacteraemia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Enterococcal bacteraemia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Stent related infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Arterial injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Device breakage | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Device failure | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Device migration | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Device occlusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Gastrointestinal injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Medical device complication | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Stent occlusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Stent-graft endoleak | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Laboratory test abnormal | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Refractory anaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Aortic surgery | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
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| Coronary artery bypass | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
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| Aorto-duodenal fistula | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Arterial thrombosis limb | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Haemorrahage | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Iliac artery occlusion | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Iliac artery thrombosis | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Vascular pseudoaneurysm | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter site haematoma | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Device breakage | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Stent-graft endoleak | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen Holthe, Clinical Project Manager | Boston Scientific | 651-581-4632 | Colleen.Holthe@bsci.com |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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