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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT03894033
Eligibility Criteria:
Inclusion Criteria
* ≥18 and ≤ 80 years of age (male or female)
* One of the following diagnosed within 14 days:
* Acute DeBakey type I dissection based on CT angiography; or
* IMH based on CT angiography
Exclusion Criteria
General Exclusion Criteria:
* \< 18 years of age or \> 80 years of age (male or female)
* Unwilling to comply with the follow-up schedule
* Refusal to give Informed Consent
Medical Exclusion Criteria:
* Uncontrolled systemic infection
* Uncontrollable anaphylaxis to iodinated contrast
* Known allergy(ies) to nitinol and/ or PTFE
* Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
* Preoperative coma
Anatomical Exclusion Criteria:
* Any pathology of mycotic origin
* Subacute or chronic dissection of the ascending aorta and aortic arch (\>14 days after the index event)
* Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
* Extensive thrombus or calcification in the aortic arch as defined by CT angiography
* Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03894033
Study Brief:
Protocol Section:
NCT03894033