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Low subject enrollment due to obseleted product.
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The primary endpoint is successful secondary endovascular treatment with the Talent Converter stent graft of subjects having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the Talent or AneuRx Bifurcated Stent Grafts, in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation.
Treatment success is defined as a composite of successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit.
Converter PAS is an observational study. Patients will receive treatment regardless of study participation. In some cases, patients will be enrolled retrospectively, post implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Successful Secondary Endovascular Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System | Device | All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Successful Secondary Endovascular Treatment | The outcome measure is successful secondary endovascular treatment with the Talent Converter stent graft where treatment success is defined as successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who are treated with the Talent Converter Stent Graft according to the indications for use
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Enrolled Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All subject enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Subjects With Successful Secondary Endovascular Treatment | The outcome measure is successful secondary endovascular treatment with the Talent Converter stent graft where treatment success is defined as successful vessel access, successful insertion of the delivery system, successful deployment of the Converter stent graft at the intended treatment site and absence of Type I endoleak at the 1 month follow-up visit. | Number of Participants with Successful Secondary Endovascular Treatment | Posted | Count of Participants | Participants | 30 days |
|
5 years
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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 | All Enrolled Subjects | Talent Converter Stent Graft and Talent Occluder with Occluder Delivery System: All Subjects enrolled will be attempted to be treated with or will be treated with the Talent Converter Stent Graft. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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FDA allowed for early termination of the Talent Converter PAS because the device is no longer being manufactured, and exsisting inventory of the device has since expired, thus no statistical conclusions will be derived due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rianna Rapson | Medtronic | 763-526-2170 | rianna.k.rapson@medtronic.com |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 10 |
| 20 |
| 11 |
| 20 |
| 0 |
| 20 |
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Device Dislocation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Stent-Graft Endoleak | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nephropathy Toxic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Aneurysm Ruptured | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D001018 |
| Aortic Diseases |