|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210032 / PAS002 |
| Date Original Protocol Accepted |
07/08/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
Post-Market Surveillance Study
|
| Device Name |
GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance is a single-arm, non-randomized, multicenter registry collecting data from consecutively treated Patients. The objective is
to ensure that the clinical outcomes during the commercial use of the GORE® TAG® Thoracic Branch Endoprosthesis are as anticipated.
|
| Study Population |
Patients who undergo treatment with the GORE® TAG® Thoracic Branch Endoprosthesis at Sites participating in the SVS VQI.
|
| Sample Size |
Max number of Patients: 350
Proximal Landing Zone: Zone 2 (per Study protocol)
Min number of Patients: 250
Min number of Patients enrolled by new Sites*: 60
Min number of Patients for specific pathologies:
• Acute Type B Dissection: 45
• Other Isolated Lesions (including PAU and IMH): 20
• Traumatic Transections: 25
A minimum of 100 evaluable Patients in Zone 2 will be available at 5-years. The minimum number of evaluable Patients at 5-years for specific pathologies will be:
• Acute Type B Dissection: 13
• Other Isolated Lesions (including PAU and IMH): 6
Traumatic Transections: 7
|
| Key Study Endpoints |
Procedural Success: Device Technical Success and the absence of the following through the 1-Month follow-up window (181 days):
• Mortality (device- and disease or treatment-related)
• Stroke (mRS = 2) (through 30-days)
• Paraplegia / Paraparesis (through 30-days)
• Aortic rupture
• Type I/III endoleak
• Branch vessel occlusion requiring reintervention
• Additional surgical or interventional procedure related to the device or treatment (Reintervention)
Treatment Success: Device Technical Success and absence of the following through all follow-up windows (unless indicated)
• Mortality (device- and disease or treatment-related)
• Stroke (mRS = 2) (through 30-days only)
• Paraplegia / Paraparesis (through 30-days only)
• Aortic enlargement in the region encompassed by the initial lesion
• Aortic rupture
• Type I/III endoleak
• New dissections
• Loss of device integrity
• Device migration
• Loss of aortic/aortic branch patency
• Additional surgical or interventional procedure related to the device or procedure (Reintervention)
Additional endpoints of interest through all follow-up windows unless indicated:
• Access complications requiring additional intervention (procedural / periprocedural only)
• Stroke (mRS = 2)
• All-cause mortality
• New dissections requiring additional intervention / reintervention
• All endoleaks
• Branch vessel occlusion requiring reintervention
• False lumen status (dissection pathology only)
False lumen perfusion source (dissection pathology only)
|
| Follow-up Visits and Length of Follow-up |
120 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
90
|
| Actual Number of Sites Enrolled |
27
|
| Patient Follow-up Rate |
53/73 (72.6%) of subjects with clinical data at 1-month, 3/55 (5.5%) of subjects with calinical data at 1-year. 47/73 (64.4%) subjects with CT imaging at 1-month, 2/55 (3.6%) with CT imaging at 1-year. No subjects lost to follow-up and withdrawals. 52/555 (94.5%) subjects with follow-up pending at 1-year.
|
| Final Safety Findings |
n/a: Insufficient information available for any safety
conclusions
|
| Final Effect Findings |
n/a: Insufficient information available for any effectiveness
conclusions
|
