Thoracic Diseases
Conditions
Keywords
CTAG, TEVAR
Brief 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.
Detailed description
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.
Interventions
DEVICECTAG 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.
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Signed informed consent form 3. Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements 4. Surgical indication for TEVAR based on investigator's best medical judgment 5. Intent to treat with CTAG Device with ACTIVE CONTROL.
Exclusion criteria
1. Paraplegia or paraparesis at initial presentation 2. Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor 3. Prior implantation of a thoracic stent graft 4. Pregnant or breast-feeding female at time of informed consent signature 5. Life expectancy \< 1 year due to comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Procedural Technical Success | 24 hours | Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion |
| Number of Subjects With Treatment Success at 30 Day Visit | One month | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Freedom From Major Adverse Events at 12 Months | 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 |
| Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | Days 30, 365, and 455 | Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis. |
| Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | One year | One year change from first post-implant CT scan in maximum aortic diameter |
| Number of Subjects With Treatment Success at 12 Month Visit | One year | Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration |
| Change in Minimum True Lumen Diameter Among Dissection | One year | One year change from first post-implant CT scan in minimum true lumen diameter |
| Change in Maximum Aortic Diameter Among Dissection | One year | One year change from first post-implant CT scan in maximum aortic diameter |
| Change in Maximum False Lumen Diameter Among Dissection | One year | One year change from first post-implant CT scan in maximum false lumen diameter |
| Number of Subjects With Freedom From Major Adverse Events at 30 Days | 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 |
Countries
France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CTAG Device With ACTIVE CONTROL All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
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. | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Scheduling difficulty | 4 |
Baseline characteristics
| Characteristic | CTAG Device With ACTIVE CONTROL | — |
|---|---|---|
| Age, Continuous | 67.1 Years STANDARD_DEVIATION 12.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 7 participants | — |
| Region of Enrollment Germany | 39 participants | — |
| Region of Enrollment Italy | 24 participants | — |
| Region of Enrollment Netherlands | 33 participants | — |
| Region of Enrollment Spain | 10 participants | — |
| Region of Enrollment Sweden | 9 participants | — |
| Region of Enrollment United Kingdom | 5 participants | — |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 92 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 127 |
| other Total, other adverse events | 0 / 127 |
| serious Total, serious adverse events | 45 / 127 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | Number of Subjects With Procedural Technical Success | 123 Participants |
Primary
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
Population: Includes all subjects with treatment failure within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a treatment failure within 30 days and with less than 15 days of follow-up were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | Number of Subjects With Treatment Success at 30 Day Visit | 115 Participants |
Secondary
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
Population: Includes all non-dissection subjects who have both post-procedure and 12-month measurements.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | >= 5mm Decrease | 20 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | No Change | 22 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion | >= 5mm Increase | 5 Participants |
Secondary
Change in Maximum Aortic Diameter Among Dissection
One year change from first post-implant CT scan in maximum aortic diameter
Time frame: One year
Population: Includes all dissection subjects who have both post-procedure and 12-month measurements.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Dissection | >= 5mm Decrease | 14 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Dissection | No Change | 10 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum Aortic Diameter Among Dissection | >= 5mm Increase | 2 Participants |
Secondary
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
Population: Includes all dissection subjects who have both post-procedure and 12-month measurements.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | Change in Maximum False Lumen Diameter Among Dissection | >= 5mm Decrease | 15 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum False Lumen Diameter Among Dissection | No Change | 10 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Maximum False Lumen Diameter Among Dissection | >= 5mm Increase | 1 Participants |
Secondary
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
Population: Includes all dissection subjects who have both post-procedure and 12-month measurements.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | Change in Minimum True Lumen Diameter Among Dissection | >= 5mm Decrease | 5 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Minimum True Lumen Diameter Among Dissection | No Change | 11 Participants |
| CTAG Device With ACTIVE CONTROL | Change in Minimum True Lumen Diameter Among Dissection | >= 5mm Increase | 10 Participants |
Secondary
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
Population: Includes all subjects with a Major Adverse Event within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a Major Adverse Event within 12 months and with less than 275 days of follow-up were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | Number of Subjects With Freedom From Major Adverse Events at 12 Months | 90 Participants |
Secondary
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
Population: Includes all subjects with a Major Adverse Event within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a Major Adverse Event within 30 days and with less than 15 days of follow-up were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | Number of Subjects With Freedom From Major Adverse Events at 30 Days | 105 Participants |
Secondary
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
Population: Includes all subjects with treatment failure within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a treatment failure within 12 months and with less than 275 days of follow-up were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device With ACTIVE CONTROL | Number of Subjects With Treatment Success at 12 Month Visit | 97 Participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTAG Device With ACTIVE CONTROL | Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | 30 Days | 0.826 Probability |
| CTAG Device With ACTIVE CONTROL | Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | 365 Days | 0.699 Probability |
| CTAG Device With ACTIVE CONTROL | Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events | 455 Days | 0.628 Probability |