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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P210032 S015/ PAS002 |
| Date Original Protocol Accepted |
08/21/2025
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| Date Current Protocol Accepted |
08/21/2025
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| Study Name |
GORE TAG TBE Zone 0/1 New Enrollment PAS
|
| Device Name |
GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
|
| Clinical Trial Number(s) |
NCT02777528
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| General Study Protocol Parameters |
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure follow-up for subjects treated with the TBE Device in Zone 0/1 as a part of routine clinical practice.
|
| Study Population |
Patients presenting with thoracic aortic disease who may benefit from the placement of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in Zone 0 or Zone 1.
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| Sample Size |
Number of subjects: Minimum of 125 subjects
Assumptions for sample size estimation: A minimum sample size of 125 subjects with at least 50 subjects evaluable at 5 years post implantation.
Number of sites: 50
Sites location: USA
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| Key Study Endpoints |
Primary:
-Initiation of the index endovascular procedures following the surgical revascularization procedure
-Device technical success (index endvascular procedure only)
-Absence of the following through all follow-up windows (unless indicated):
-lesion-related mortality
-Disabling Stroke (within 30 days)
-Permanent Paraplegia (within 30 days)
-Permanent Paraparesis (within 30 days)
-New onset renal failure (within 30 days) requiring ongoing analysis
- Lesion rupture (treated area)
- Loss of aortic or branch patency
-Endoleaks
-Reintervention
Secondary:
The following endpoints will be assessed through all follow-up windows (unless indicated)
-Access-related complications (index endovascular procedure only)
-Life threatening bleed (index endovascular procedure only)
-All-cause mortality
-Stroke
-Transient ischemic attach (TIA)
- Paraplegia (within 30 days)
-Paraparesis (within 30 days)
- Myocardial infarction (within 30 days)
- Laryngeal or Phrenic nerve injury (within 30 days)
- Distal device-related thromboembolic adverse event requiring intervention or surgery (through 1-month)
-Fistula formation
- Upper extremity ischemia
- Lesion enlargement (treated area)
- Device migration
- New dissection (with / without treatment)
- Device and treatment-related Adverse Events (AEs)
- Serious Adverse Events (SAEs)
- Device integrity events (e.g., fracture, kinking, compression)
- False lumen status (dissection pathology)
-False lumen perfusion (dissection pathology)
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| Follow-up Visits and Length of Follow-up |
Frequency of Follow-up:
Pre-treatment (Screening), Treatment, Discharge, and Follow-up (1 Month, 6 Month, 1 Year, and Annually Thereafter for a minimum of 5-years and up to a maximum of 10 years)
Length of Follow-up:
Minimum of 5 years and Maximum of 10 years
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