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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05174767
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age or ≤80 years of age (male or female) at time of surgery
* Acute DeBakey type I dissection based on computed tomography angiography (CTA) and diagnosed ≤14 days from of the index event
* Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)
Exclusion Criteria:
* Other medical condition that is associated with limited life expectancy \<2 years (e.g., cancer, congestive heart failure)
* Pregnant or breastfeeding.
* Unwilling to comply with the follow-up schedule
* Institutionalized due to administrative or judicial order
* Unwilling to accept blood transfusions for any reason
* Coronary malperfusion
* In circulatory shock (i.e., systolic blood pressure \<90 mmHg) at time of screening
* In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time of screening
* Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and/or acidosis)
* Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage
* Base deficit \> -10 mmol/L or -10 mEq/L
* American Society of Anesthesiologists risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) or class VI (a declared brain dead patient whose organs are being removed for donor purposes)
* Previous placement of a thoracic endovascular graft
* Interventional and/or open surgical procedures 30 days prior to the dissection repair
* Planned major interventional and/or open surgical procedures 30 days post the dissection repair
* Systemic infection
* Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed suitable by the Investigator)
* Known allergy(ies) to nitinol and/or polytetrafluoroethylene
* Inability to obtain CT angiograms for follow-up
* Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietz syndrome based on laboratory genetic testing
* Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis
* Diagnosed with severe and catastrophic neurological complications in the 30 days prior to the dissection diagnosis (namely, obtundation or coma)
* Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min)
* History of bleeding disorder (i.e. hemophilia)
* A primary entry tear that extends into the arch or distal to the left subclavian artery
* Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), for any reason as deemed necessary by the Investigator
* Any pathology of mycotic origin
* Aortic fistulous communication with non-vascular structure (e.g., esophagus, bronchial)
* Extensive thrombus or calcifications in the aortic arch, as defined by CTA
* Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA
* Descending thoracic aneurysm involving the proximal third (one-third) of the descending aorta and measuring \>45 mm in diameter
* Aortic arch aneurysm \>50 mm in diameter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05174767
Study Brief:
Protocol Section:
NCT05174767