Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

Launched by JOTEC GMBH · Mar 27, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a medical device called the Ascyrus Medical Dissection Stent (AMDS) to treat patients with a serious condition known as acute DeBakey type I aortic dissection. This condition involves a tear in the wall of the aorta, the main blood vessel that carries blood from the heart to the rest of the body, which can lead to complications as blood flows through both the main channel and a secondary abnormal channel created by the tear. The study aims to gather information on how well the AMDS works and its benefits for patients who have recently been diagnosed with this condition.

To be eligible for the trial, participants need to be between 18 and 80 years old and must have been diagnosed with acute DeBakey type I dissection or another related condition within the last 14 days. Participants will receive the AMDS stent as part of their standard care, and the trial will involve follow-up appointments to monitor their progress. It's important to note that patients with certain medical conditions or health risks may not qualify for the study. Overall, this trial aims to improve treatment options for people facing this life-threatening condition.

Gender

ALL

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