Phase 3
Completed N=100
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Aneurysm, Dissecting · Aortic Aneurysm, Thoracic
Source: ClinicalTrials.gov NCT00757003 ↗
Enrolled (actual)
100
Serious AEs
43.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Technically Successful Implant — 99.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
PURPOSE OF RESEARCH:
Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to open surgery that may decrease morbidity and mortality, particularly in high risk patients. Optimal patient selection, based on pathology and anatomy, is being defined. Technically successful implantation requires adequate assessment of pathology and anatomy, and development and execution of novel and delicate procedures that resolve the pathology while minimizing morbidity and mortality.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Technically Successful Implant |
99.0 | — |
| SECONDARY Count of Participants Experiencing at Least One Endoleak Following Procedure |
32 | — |
| SECONDARY Overall Survival |
51 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should be poor or high risk open surgical candidates.
- Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
- Anatomy meets TAG Endoprosthesis specification criteria.
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- 4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
- Significant thrombus at the proximal or distal implantation sites.
- Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
- Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
- Female of child bearing age with positive pregnancy test.
Data sourced from ClinicalTrials.gov (NCT00757003). 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. Informational only — not medical advice.