N/A
N=55
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Thoracic Aortic Aneurysm · Thoracic Aorta Injury · Thoracic Aortic Dissection
Bottom Line
View on ClinicalTrials.gov: NCT05414318 ↗Enrolled (actual)
55
Serious AEs
32.7%
Results posted
Oct 2024
Primary outcome: Primary: Primary Entry Tear Exclusion — 21; 26; 27; 22 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Conformable GORE® TAG® Thoracic Endoprosthesis (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Entry Tear Exclusion |
21; 26; 27; 22; 19; 17 | — |
| PRIMARY Aortic Rupture |
2 | — |
| PRIMARY Major Device-related Adverse Events |
3; 0 | — |
| PRIMARY Secondary Intervention Treatment |
5; 0 | — |
| PRIMARY Change in Minimum True Lumen Diameter Adjacent to Treated Segment |
1; 6; 18; 1; 3; 26 | — |
| PRIMARY Change in Minimum True Lumen Diameter Distal to Treated Segment |
0; 13; 11; 1; 11; 14 | — |
| PRIMARY Change in Maximum False Lumen Diameter Adjacent to Treated Segment |
18; 5; 1; 23; 4; 0 | — |
| PRIMARY Change in Maximum False Lumen Diameter Distal to Treated Segment |
14; 10; 0; 19; 5; 1 | — |
| PRIMARY Change in Maximum Lesion Diameter |
1; 2; 0; 1; 2; 0 | — |
Summary
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
Eligibility Criteria
Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection:
- Patient present with acute complicated type B aortic dissection
- Patient who do not respond to medical therapy
- Time from symptom onset to dissection diagnosis ≤ 14 days
- Adequate iliac / femoral access or conduit
- Aortic inner diameter at proximal extent of proximal landing zone in the range of 16-42 mm
- ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected
Inclusion Criteria for Traumatic Aortic Transection:
- Patient has traumatic aortic transection that requires repair as determined by treating physician
- Adequate iliac / femoral access
- Aortic inner diameter in the range of 16-42 mm on the proximal and distal sides
- ≥ 20 mm non-aneurysmal aorta neck proximal and distal to the lesion
Data sourced from ClinicalTrials.gov (NCT05414318). 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.