N/A
Completed N=127
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Thoracic Diseases
Source: ClinicalTrials.gov NCT03286400 ↗
Enrolled (actual)
127
Serious AEs
35.4%
Results posted
Nov 2020
Primary outcomePrimary: Number of Subjects With Procedural Technical Success — 123 Participants
Summary
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Procedural Technical Success |
123 | — |
| PRIMARY Number of Subjects With Treatment Success at 30 Day Visit |
115 | — |
| SECONDARY Number of Subjects With Freedom From Major Adverse Events at 30 Days |
105 | — |
| SECONDARY Number of Subjects With Freedom From Major Adverse Events at 12 Months |
90 | — |
| SECONDARY Number of Subjects With Treatment Success at 12 Month Visit |
97 | — |
| SECONDARY Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events |
0.826; 0.699; 0.628 | — |
| SECONDARY Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion |
20; 22; 5 | — |
| SECONDARY Change in Maximum False Lumen Diameter Among Dissection |
15; 10; 1 | — |
| SECONDARY Change in Minimum True Lumen Diameter Among Dissection |
5; 11; 10 | — |
| SECONDARY Change in Maximum Aortic Diameter Among Dissection |
14; 10; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Signed informed consent form
- Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
- Surgical indication for TEVAR based on investigator's best medical judgment
- Intent to treat with CTAG Device with ACTIVE CONTROL.
Exclusion Criteria
- Paraplegia or paraparesis at initial presentation
- Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
- Prior implantation of a thoracic stent graft
- Pregnant or breast-feeding female at time of informed consent signature
- Life expectancy < 1 year due to comorbidities
Data sourced from ClinicalTrials.gov (NCT03286400). 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.