Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT00757003
Eligibility Criteria:
Inclusion Criteria:
1. Patients should be poor or high risk open surgical candidates.
2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transection.
3. Anatomy meets TAG Endoprosthesis specification criteria.
4. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
* \<60 angle in the aortic arch may require additional length of non-aneurysmal segment is the arch is included in the treatment segment.
5. Ability to comply with protocol requirements including follow-up.
6. Signed Informed Consent
Exclusion Criteria:
1. \>4mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
2. Significant thrombus at the proximal or distal implantation sites.
3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit or alternate perfusion routes for end organ(s) provided.
4. Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome, unless the proximal and distal implantation sites of the TAG Endoprosthesis are located with in previous surgical grafts.
6\. Female of child bearing age with positive pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00757003
Study Brief:
Protocol Section:
NCT00757003