Trial Outcomes & Findings for Talent Converter Post-Approval Study (NCT NCT01129609)
NCT ID: NCT01129609
Last Updated: 2021-10-29
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
20 participants
Primary outcome timeframe
30 days
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Talent Converter Post-Approval Study
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=20 Participants
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
|
|---|---|
|
Age, Continuous
|
77.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Number of Participants 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.
Outcome measures
| Measure |
All Enrolled Subjects
n=20 Participants
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
|
|---|---|
|
Number of Subjects With Successful Secondary Endovascular Treatment
|
17 Participants
|
Adverse Events
All Enrolled Subjects
Serious events: 11 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
All Enrolled Subjects
n=20 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Cardiac disorders
Acute Myocardial Infarction
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac Arrest
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
General disorders
Device Dislocation
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
General disorders
Stent-Graft Endoleak
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
10.0%
2/20 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Nervous system disorders
Parkinson's Disease
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mental Status Changes
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Nephropathy Toxic
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal Failure Acute
|
10.0%
2/20 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.0%
1/20 • Number of events 1 • 5 years
|
|
Vascular disorders
Aneurysm Ruptured
|
5.0%
1/20 • Number of events 1 • 5 years
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place