N/A
Completed N=51
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Source: ClinicalTrials.gov NCT00874250 ↗Enrolled (actual)
51
Serious AEs
72.6%
Results posted
Dec 2011
Primary outcomePrimary: The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment — 50 participants — p=0.0024
Summary
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment |
50 | 0.0024 sig |
| SECONDARY The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. |
13 | — |
| SECONDARY Procedure Time (Minutes) |
118 | — |
| SECONDARY Operative Blood Loss (mL) |
150 | — |
| SECONDARY Days of Convalescence Stay in an Intensive Care Unit |
38 | — |
| SECONDARY Total Length of Hospital Stay (Days) |
4 | — |
| SECONDARY Time in Days to Return to Normal Daily Activities |
31 | — |
| SECONDARY Procedural Survival |
51 | — |
| SECONDARY Intensive Care Unit (ICU) Stay |
38 | — |
Eligibility Criteria
Inclusion Criteria:>
- Presence of DTA aneurysm deemed to warrant surgical repair >
- Fusiform (≥50 mm), or >
- Saccular (no diameter criteria)> 2. Subject is > 21 years of age> 3. Proximal and distal landing zone length ≥ 2.0 cm >
- Landing zones must be in native aorta>
- Landing zone may include left subclavian artery, if necessary> 4. All proximal and distal landing zone inner diameters are between 16-42 mm>
- Diameter assessed by flow lumen and thrombus, if present; calcium excluded> 5. Life expectancy > 2 years> 6. Able to tolerate thoracotomy > 7. Male or infertile female> 8. Able to comply with protocol requirements including following-up> 9. Signed informed consent>
Exclusion Criteria:>
- Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper>
- Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access>
- Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)>
- Mycotic aneurysm>
- Hemodynamically unstable aneurysm rupture>
- Aortic dissection>
- Planned coverage of left carotid or celiac arteries with the CTAG Device>
- Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date>
- Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome>
- Known history of drug abuse>
- ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)>
- NYHA class IV >
- Participating in another investigational device or drug study within 1 year of treatment>
- Subject has known sensitivities or allergies to the device materials>
- Subject has a systemic infection and may be at increased risk of endovascular graft infection>
Data sourced from ClinicalTrials.gov (NCT00874250). 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.