Abdominal Aortic Aneurysms
Conditions
Keywords
Post-approval observation of patients being treated according to the indications for use for the Talent Converter Stent Graft
Brief summary
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.
Detailed description
Converter PAS is an observational study. Patients will receive treatment regardless of study participation. In some cases, patients will be enrolled retrospectively, post implantation.
Interventions
DEVICETalent 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
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects in whom a vessel access procedure was/will be performed with the attempted introduction of the Talent Converter Stent Graft for use according to the indications for use in the Instructions for Use (IFU) 0-365 days prior to enrollment. 2. Subjects who are able to understand the nature of the study and give voluntary informed consent. 3. Subjects who are available for follow-up visits. 4. Subjects 18 years of age or older.
Exclusion criteria
1. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft other than (i.e., primary AUI) as a secondary endovascular intervention for patients having received prior endovascular repair with either a Talent or AneuRx bifurcated stent graft. 2. Subjects in whom an attempted treatment was/will be performed with the Talent Converter Stent Graft as a secondary endovascular intervention for patients having received prior endovascular repair with a bifurcated stent graft other than (i.e., Cook Zenith or Gore Excluder) a Talent or AneuRx bifurcated stent graft.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Successful Secondary Endovascular Treatment | 30 days | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 77.9 years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 11 / 20 |
Outcome results
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.
Time frame: 30 days
Population: Number of Participants with Successful Secondary Endovascular Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Enrolled Subjects | Number of Subjects With Successful Secondary Endovascular Treatment | 17 Participants |