N/A
N=10
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
Thoracoabdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02528500 ↗Enrolled (actual)
10
Serious AEs
100.0%
Results posted
Jul 2018
Primary outcome: Primary: Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL |
9 | — |
| SECONDARY Technical Success, Including Individual Components of Technical Success |
9; 10; 10; 9; 10 | — |
| SECONDARY Device Integrity, Including Individual Components of Device Integrity |
2; 0 | — |
| SECONDARY Patency (Primary, Assisted Primary, and Secondary) |
8; 8; 9 | — |
| SECONDARY Absence of Type I and Type III Endoleaks at One Month Follow-up |
8; 8 | — |
Summary
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
Eligibility Criteria
Inclusion Criteria
- Aortic aneurysm involving the visceral vessels requiring treatment
- Adequate access for TAMBE Device components
- Appropriate aortic anatomy to receive the TAMBE Device
- Age ≥ 18 years at the time of informed consent signature
- Male or infertile female
- The patient is considered high risk for open 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 Note: Additional Inclusion Criteria may apply
Exclusion Criteria
- Prior aortic surgery
- Ruptured or leaking aortic aneurysm
- Aneurysmal dilatation due to chronic aortic dissection
- Infected aorta
- Mycotic aneurysm
- Life expectancy <2 years
- Myocardial infarction or stroke within 6 weeks of treatment
- Systemic infection which may increase risk of endovascular graft infection
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or medical device study within 1 year of study enrollment
- History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
- Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
- Known sensitivities or allergies to the device materials
- Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
- Renal Insufficiency Note: Additional Exclusion Criteria may apply
Data sourced from ClinicalTrials.gov (NCT02528500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.