Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thor… (NCT03728985) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
United States102 participantsStarted 2019-06-17
Plain-language summary
Prospective, non-randomized, , multicenter study with two independent arms:
* Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
* Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only
* Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following:
✓. Aortic aneurysm that involves the abdominal aorta, with:
✓. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)
✓. Age ≥ 19 years at the time of informed consent signature
✓. Male or infertile female
✓. Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician
✓. Capable of complying with protocol requirements, including follow-up
✓. An Informed Consent Form signed by Subject or legal representative
Exclusion criteria
✕. Prior open, aortic surgery of the ascending aorta or aortic arch
✕
What they're measuring
1
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Timeframe: From start of Index Procedure to 59 Days Post Procedure
2
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality