Trial Outcomes & Findings for Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions (NCT NCT00597870)

Last Updated: 2023-09-14

Results Overview

Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..

Recruitment status

COMPLETED

Study phase

Target enrollment

304 participants

Primary outcome timeframe

Throughout study completion, an average of 1 year

Results posted on

2023-09-14

Participant Flow

Participants were recruited over several years from patients in the hospital and referrals from other hospitals, providers and clinics in the area.

Participants treated

Participant milestones

Participant milestones
Measure	Endoluminal Treatment of Thoracic Lesions Successful endoluminal treatment of thoracic lesion with a thoracic stent graft
Overall Study STARTED	304
Overall Study COMPLETED	304
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Number of Patients n=304 Participants Endoluminal treatment of thoracic aneurysm, dissection, pseudoaneurysm, aortic ulcer, transection and other thoracic lesion.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	304 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	92 Participants n=5 Participants
Sex: Female, Male Male	212 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	125 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	70 Participants n=5 Participants
Race (NIH/OMB) White	199 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	304 Participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout study completion, an average of 1 year

Population: Only 294 participants out of the 304 initial participants were assessed for this Outcome measure.

Evaluate the number of patients who had successful treatment of their thoracic lesion using the Medtronic Talent Endoluminal Stent Graft..

Outcome measures

Outcome measures
Measure	Participants Whose Thoracic Lesions Were Successfully Excluded and Treated n=294 Participants Evaluate the number of patients whose thoracic stent-graft was successful in preventing blood to flow into the blood vessels during the initial surgery.
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion	294 Participants

SECONDARY outcome

Timeframe: Throughout study completion, an average of 1 year

Population: Only 294 participants out of the initial 304 participants were assessed for this outcome measure.

Evaluate the number of patients where the thoracic device was successfully delivered and deployed within the patients' thoracic lesion.

Outcome measures

Outcome measures
Measure	Participants Whose Thoracic Lesions Were Successfully Excluded and Treated n=294 Participants Evaluate the number of patients whose thoracic stent-graft was successful in preventing blood to flow into the blood vessels during the initial surgery.
Number of Participants With Successful Device Delivery and Deployment	269 Participants

Adverse Events

Exclusion of Thoracic Lesions

Serious events: 107 serious events

Other events: 4 other events

Deaths: 86 deaths

Serious adverse events

Serious adverse events
Measure	Exclusion of Thoracic Lesions n=304 participants at risk Successful endoluluminal exclusion/treatment of thoracic lesions
Vascular disorders Endoleak	35.2% 107/304 • Number of events 107 • From treatment through 5 years
Vascular disorders Aortic Dissection	2.3% 7/304 • Number of events 7 • From treatment through 5 years
Renal and urinary disorders Acute renal failure	3.0% 9/304 • Number of events 9 • From treatment through 5 years
Cardiac disorders MI	4.6% 14/304 • Number of events 14 • From treatment through 5 years
General disorders Stroke	4.6% 14/304 • Number of events 14 • From treatment through 5 years
Surgical and medical procedures Infection	2.6% 8/304 • Number of events 8 • From treatment through 5 years
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.3% 7/304 • Number of events 7 • From treatment through 5 years
General disorders Transient paralysis	1.6% 5/304 • Number of events 5 • From treatment through 5 years

Other adverse events

Other adverse events
Measure	Exclusion of Thoracic Lesions n=304 participants at risk Successful endoluluminal exclusion/treatment of thoracic lesions
Surgical and medical procedures Hematoma	1.3% 4/304 • Number of events 4 • From treatment through 5 years

Additional Information

Rodney A. White, MD

Lundquist Institute of BioMedical Studies

Phone: 3109635230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place