An observational study in Thoracic Diseases, sponsored by W.L.Gore & Associates. Completed at 20 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by W.L.Gore & Associates · Observational
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.
This is an observational, prospective, single-arm, post-market registry designed to 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. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.
72 studies on the registry are indexed under Thoracic Diseases; 13 are open to participants now.
This study's enrollment of 127 is close to the median of 122 across 19 observational studies indexed under Thoracic Diseases.
Browse Thoracic Diseases studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients presenting with an indication for endovascular repair of the thoracic aorta are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
Device: CTAG Device with ACTIVE CONTROL
Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
Number of Subjects With Procedural Technical Success
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Time frame: 24 hours
Number of Subjects With Treatment Success at 30 Day Visit
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
Time frame: One month
Number of Subjects With Freedom From Major Adverse Events at 30 Days
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
Time frame: 30 Days
Number of Subjects With Freedom From Major Adverse Events at 12 Months
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
Time frame: 12 Months
Number of Subjects With Treatment Success at 12 Month Visit
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
Time frame: One year
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
Time frame: Days 30, 365, and 455
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
One year change from first post-implant CT scan in maximum aortic diameter
Time frame: One year
Change in Maximum False Lumen Diameter Among Dissection
One year change from first post-implant CT scan in maximum false lumen diameter
Time frame: One year
Change in Minimum True Lumen Diameter Among Dissection
One year change from first post-implant CT scan in minimum true lumen diameter
Time frame: One year
Change in Maximum Aortic Diameter Among Dissection
One year change from first post-implant CT scan in maximum aortic diameter
Time frame: One year
| Milestone | CTAG Device With ACTIVE CONTROL |
|---|---|
| Started | 127 |
| Completed | 102 |
| Not completed | 25 |
| Withdrew: Death | 10 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Physician decision | 1 |
| Withdrew: Scheduling difficulty | 4 |
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| Number of Subjects With Procedural Technical Success | 123 |
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| Number of Subjects With Treatment Success at 30 Day Visit | 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
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| Number of Subjects With Freedom From Major Adverse Events at 30 Days | 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
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| Number of Subjects With Freedom From Major Adverse Events at 12 Months | 90 |
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| Number of Subjects With Treatment Success at 12 Month Visit | 97 |
Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
| Probability | CTAG Device With ACTIVE CONTROL |
|---|---|
| 30 Days | 0.826 (0.748 to 0.882) |
| 365 Days | 0.699 (0.609 to 0.772) |
| 455 Days | 0.628 (0.487 to 0.740) |
One year change from first post-implant CT scan in maximum aortic diameter
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| >= 5mm Decrease | 20 |
| No Change | 22 |
| >= 5mm Increase | 5 |
One year change from first post-implant CT scan in maximum false lumen diameter
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| >= 5mm Decrease | 15 |
| No Change | 10 |
| >= 5mm Increase | 1 |
One year change from first post-implant CT scan in minimum true lumen diameter
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| >= 5mm Decrease | 5 |
| No Change | 11 |
| >= 5mm Increase | 10 |
One year change from first post-implant CT scan in maximum aortic diameter
| Participants | CTAG Device With ACTIVE CONTROL |
|---|---|
| >= 5mm Decrease | 14 |
| No Change | 10 |
| >= 5mm Increase | 2 |
Collected over 455 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | 10/127 (7.9%) | 45/127 (35.4%) | 0/127 (0%) |
| Event | CTAG Device With ACTIVE CONTROL |
|---|---|
| Stent-graft endoleakGeneral disorders | 9/127 |
| Aortic aneurysmVascular disorders | 3/127 |
| Aortic dissectionVascular disorders | 3/127 |
| Myocardial infarctionCardiac disorders | 2/127 |
| DeathGeneral disorders | 2/127 |
| PneumoniaInfections and infestations | 2/127 |
| SepsisInfections and infestations | 2/127 |
| Urinary tract infectionInfections and infestations | 2/127 |
| Vascular graft haemorrhageInjury, poisoning and procedural complications | 2/127 |
| Vascular procedure complicationInjury, poisoning and procedural complications | 2/127 |
| Age, Continuous(Years) | CTAG Device With ACTIVE CONTROL |
|---|---|
| Mean | 67.1 ± 12.1 |
| Sex: Female, Male(Participants) | CTAG Device With ACTIVE CONTROL |
|---|---|
| Female | 35 |
| Male | 92 |
| Race and Ethnicity Not Collected(Participants) | CTAG Device With ACTIVE CONTROL |
|---|
| Region of Enrollment(participants) | CTAG Device With ACTIVE CONTROL |
|---|---|
| Netherlands | 33 |
| Sweden | 9 |
| Italy | 24 |
| United Kingdom | 5 |
| France | 7 |
| Germany | 39 |
| Spain | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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