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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT01839695
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years of age.
* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
* Subject must be considered a candidate for revascularization of the LSA.
* Subject has a DTA which will require coverage of the LSA
* Subject's anatomy must meet the anatomical criteria to receive that implanted device
Exclusion Criteria:
* Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta.
* Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL
* Subject is a pregnant female.
* Enrollment in another clinical study
* Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months.
* Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
* Subject has a known allergy or intolerance to the device components.
* Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01839695
Study Brief:
Protocol Section:
NCT01839695