Clinical trial NCT06578741: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Official title: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Pararenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.

Detailed description: A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Eligibility criteria: Inclusion Criteria:

The subject is / has:

1. Treated with the aortic component of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Aortic Component) to allow endovascular repair of an aortic disease involving the visceral vessels.
2. Age ≥18 years at the time of informed consent signature.
3. An Informed Consent Form signed by subject or legal representative.

Exclusion Criteria:

The subject is / has:

1. Any contraindications for the TAMBE Device according to the IFU.
2. Planned parallel grafting with the TAMBE Aortic Component.
3. Intent to modify TAMBE Aortic Component (e.g., in situ fenestration).

Primary outcomes:
measure: Co-Primary Endpoint #1: Technical Success
timeFrame: Time of index procedure
measure: Co-Primary Endpoint #2: Clinical Success
timeFrame: Index procedure through 12 months
Secondary outcomes:
measure: Target Vessel Technical Success
timeFrame: 30 days, 6 months, annually through 10 years
measure: Secondary Clinical Success
timeFrame: 30 days, 6 months, annually through 10 years
measure: Assisted Primary Clinical Success
timeFrame: 30 days, 6 months, annually through 10 years
measure: Thirty-Day Mortality
timeFrame: 30 days
measure: Lesion-Related Mortality
timeFrame: 30 days, 6 months, annually through 10 years
measure: Major Adverse Events (MAEs)
timeFrame: 30 days, 6 months, annually through 10 years
measure: Secondary interventions
timeFrame: Time of index procedure
measure: Intraprocedural Complications
timeFrame: 30 days, 6 months, annually through 10 years
measure: Kink
timeFrame: 30 days, 6 months, annually through 10 years
measure: Stenosis
timeFrame: 30 days, 6 months, annually through 10 years
measure: Occlusion
timeFrame: 30 days, 6 months, annually through 10 years
measure: Target Vessel Instability
timeFrame: 30 days, 6 months, annually through 10 years
measure: Secondary Patency
timeFrame: 30 days, 6 months, annually through 10 years
measure: Primary Assisted Patency
timeFrame: 30 days, 6 months, annually through 10 years
measure: Primary Patency
timeFrame: 30 days, 6 months, annually through 10 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital
state: California
Study officials:
References: