Trial Outcomes & Findings for Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA) (NCT NCT00695253)
NCT ID: NCT00695253
Last Updated: 2023-02-15
Results Overview
The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
From the date of treatment assessed up to 5 years post treatment.
Results posted on
2023-02-15
Participant Flow
About 75 patients were screened for eligibility for enrollment in the study based on the inclusion/exclusion criteria. Participants were selected over a 7 year period between 2002 and 2008 and were made up of patients in the hospital, clinic patients as well as those referred from other clinics and facilities.
Participant milestones
| Measure |
Talent Endoluminal Spring Graft System
All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
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|---|---|
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Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
Baseline characteristics by cohort
| Measure |
There Are no Study Arms.
n=49 Participants
All participants who were diagnosed with abdominal aortic aneurysms and who were eligible for enrollment as defined by the inclusion/exclusion criteria were screened. These patients included both high and low risk patients who signed a consent to participate in this Physician-sponsored IDE for the endoluminal treatment of their abdominal aneurysm using the Medtronic/Talent Stent Graft: Stent-graft for Abdominal Aortic Aneurysms.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=93 Participants
|
|
Age, Continuous
|
74.64 years
STANDARD_DEVIATION 3.78 • n=93 Participants
|
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Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the date of treatment assessed up to 5 years post treatment.The safety and effectiveness of the endoluminal device was determined by the number participants with successful exclusion of the abdominal aortic aneurysm (AAA).
Outcome measures
| Measure |
Number of Successful Exclusion of Abdominal Aortic Aneurysms
n=49 Participants
The safety and effectiveness of the endoluminal device was determined by the number of abdominal aortic aneurysms (AAA) that were successfully excluded.
|
|---|---|
|
Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm
|
49 participants' AAA
|
SECONDARY outcome
Timeframe: From the date of treatment assessed up to 5 years post treatment.Delivery success is defined as the successful access of the vessel and insertion of the delivery sheath to the treatment site. Deployment success is defined as the advancement through the vasculature to the desired location and full deployment within 0.5 cm of the intended location. Aneurysm exclusion is achieved when there is no evidence of blood flow around or through the stent graft into the aneurysm or where there is an absence of contrast within the aneurysm sac.
Outcome measures
| Measure |
Number of Successful Exclusion of Abdominal Aortic Aneurysms
n=49 Participants
The safety and effectiveness of the endoluminal device was determined by the number of abdominal aortic aneurysms (AAA) that were successfully excluded.
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|---|---|
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Number of Participants With Successful Device Delivery and Deployment
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49 Participants
|
Adverse Events
Talent Endoluminal Spring Stent Graft System
Serious events: 29 serious events
Other events: 4 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Talent Endoluminal Spring Stent Graft System
n=49 participants at risk
Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft: Stent-graft for all patients with abdominal aortic lesions who signed consent into this Physician - Sponsored IDE.
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|---|---|
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Cardiac disorders
Myocardial infarction
|
4.1%
2/49 • Number of events 2 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Vessel Injury
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2.0%
1/49 • Number of events 1 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Cancer
|
12.2%
6/49 • Number of events 6 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Cardiac disorders
Congestive Heart Failure
|
4.1%
2/49 • Number of events 2 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Endoleak
|
18.4%
9/49 • Number of events 9 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Ruptured AAA
|
2.0%
1/49 • Number of events 1 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Ruptured TAA
|
2.0%
1/49 • Number of events 1 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Renal and urinary disorders
Renal Cancer
|
2.0%
1/49 • Number of events 1 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Reproductive system and breast disorders
Prostate cancer
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2.0%
1/49 • Number of events 1 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Stent Graft migration
|
4.1%
2/49 • Number of events 2 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Stent Graft occlusion
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6.1%
3/49 • Number of events 3 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
Other adverse events
| Measure |
Talent Endoluminal Spring Stent Graft System
n=49 participants at risk
Endoluminal treatment of abdominal aortic aneurysms using the Medtronic/Talent Stent Graft: Stent-graft for all patients with abdominal aortic lesions who signed consent into this Physician - Sponsored IDE.
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|---|---|
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Vascular disorders
Hypertension
|
4.1%
2/49 • Number of events 2 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
|
|
Vascular disorders
Peripheral Vascular Disease
|
4.1%
2/49 • Number of events 2 • From the data of treatment until the date of death from any event or the date of the adverse event assessed up to five years. Participants were followed for the duration of the study, an average of 5 years.
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Additional Information
Rodney A. White, M. D.
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Phone: 310 963-5230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place