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Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
trial testing CTAG Device with ACTIVE CONTROL in Thoracic Diseases in 127 participants. Completed in 9 October 2019.
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 127 |
| Start date | 18 October 2017 |
| Primary completion | 9 October 2019 |
| Estimated completion | 9 October 2019 |
| Sites | 20 locations across France, Italy, Netherlands, Sweden, United Kingdom, Germany, Spain |
W.L.Gore & Associates — full company profile →
18 and older, any sex, with Thoracic Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 123 |
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 115 |
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 105 |
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 90 |
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 97 |
Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 0.826 | 0.748 – 0.882 |
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 0.699 | 0.609 – 0.772 |
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 0.628 | 0.487 – 0.740 |
One year change from first post-implant CT scan in maximum aortic diameter
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 20 | |
| CTAG Device With ACTIVE CONTROL | 22 | |
| CTAG Device With ACTIVE CONTROL | 5 |
One year change from first post-implant CT scan in maximum false lumen diameter
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 15 | |
| CTAG Device With ACTIVE CONTROL | 10 | |
| CTAG Device With ACTIVE CONTROL | 1 |
One year change from first post-implant CT scan in minimum true lumen diameter
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 5 | |
| CTAG Device With ACTIVE CONTROL | 11 | |
| CTAG Device With ACTIVE CONTROL | 10 |
One year change from first post-implant CT scan in maximum aortic diameter
| Group | Value | 95% CI |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | 14 | |
| CTAG Device With ACTIVE CONTROL | 10 | |
| CTAG Device With ACTIVE CONTROL | 2 |
Time frame: 455 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CTAG Device With ACTIVE CO… |
|---|---|---|
| Stent-graft endoleak | General disorders | — |
| Aortic aneurysm | Vascular disorders | — |
| Aortic dissection | Vascular disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Death | General disorders | — |
| Pneumonia | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Vascular graft haemorrhage | Injury, poisoning and procedural complications | — |
| Vascular procedure complication | Injury, poisoning and procedural complications | — |
| Paraplegia | Nervous system disorders | — |
| Spinal cord ischaemia | Nervous system disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Palpitations | Cardiac disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Aorto-oesophageal fistula | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Intestinal ischaemia | Gastrointestinal disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Multiple organ dysfunction syndrome | General disorders | — |
| Vascular stent occlusion | General disorders | — |
| Infective aneurysm | Infections and infestations | — |
| Vascular device infection | Infections and infestations | — |
| Anastomotic stenosis | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Stent-graft endoleak, Aortic aneurysm, Aortic dissection, Myocardial infarction, Death, Pneumonia, Sepsis, Urinary tract infection.
Data from ClinicalTrials.gov NCT03286400 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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