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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02524834
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a Type IV complex thoracoabdominal aortic lesion and be considered candidates for endovascular repair;
* Patients must have an ileofemoral access compatible with delivery of a 25 Fr MedtronicValiant thoracic endograft;
* Patients must have a left subclavian artery anatomy compatible with 8 mm Dacron conduit to provide safe, sequential antegrade deployments of branch extensions
* Patients must have a nonaneurysmal proximal aortic segment distal to the left subclavian artery with at least 2 cm length to assure secure proximal fixation with a
* Minimum diameter of 28 mm
* Maximum diameter of 42mm
* Angle less than 60° relative to axis of the aneurysm
* Angle less than 60° relative to axis of the thoracic aorta;
* Patients must have a distal fixation iliac artery diameter greater than 2 cm in length and 12-28 mm in diameter;
* Patients must be high-risk surgical candidates according to the following established criteria: ASA score of IV.
Exclusion Criteria:
* Pregnant or pediatric patients (younger than 21 years of age);
* Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis;
* Patients with allergies to the stent graft material;
* Patients who fail to sign informed consent;
* Patients with expected survival less than one year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT02524834
Study Brief:
Protocol Section:
NCT02524834