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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT01107366
Eligibility Criteria:
Inclusion Criteria:
1. Patient willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious.
and
2. Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (\>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery).
Or
3. Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:
* An initial false lumen diameter measured in the upper descending thoracic aorta \>22 mm;
* Total aortic diameter measured in the descending thoracic aorta \>45 mm;
* True lumen's compression (True lumen \<10% of total aortic lumen);
* Non-controlled hypertension;
* Persistent pain;
* Rupture or imminent rupture;
Exclusion Criteria:
1. Patient has a standard contraindication to the implant of thoracic stent graft;
2. Patient unable to commit to follow-up schedule;
3. Patient has medical conditions that preclude protocol required testing or limit study participation;
4. Patient is enrolled or intend to participate in another clinical trial during the course of this study;
5. Less than 18 years of age;
6. Pregnancy;
7. A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01107366
Study Brief:
Protocol Section:
NCT01107366