Status:
COMPLETED
DARTS I: Feasibility, Safety, and Performance Trial
Lead Sponsor:
Ascyrus Medical LLC.
Collaborating Sponsors:
Artivion Inc.
Conditions:
Acute DeBakey I Aortic Dissection
Intramural Hematoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the feasibility and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas (IMH) involving the ...
Detailed Description
AMDS is designed to complement the replacement of the ascending aorta with conventional surgical technique utilizing a conventional polyester graft. AMDS is constructed of an uncovered Nitinol wire br...
Eligibility Criteria
Inclusion
- Informed Consent obtained
- ≥18 years of age or ≤80 years of age (male or female)
- Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
- Acute DeBakey I dissection or
- Acute DeBakey I intramural hematoma (IMH)
Exclusion
- General Exclusion Criteria
- Patients must be excluded from the study if any of the following conditions are true:
- Less than 18 years of age or over 80 years of age
- Life expectancy less than 2 years
- Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Refusal to give informed consent
- Institutionalized individualized due to administrative or judicial order
- Individuals with a dependent relationship to the sponsor or investigator
- Medical Exclusion Criteria
- Patients must be excluded from the study if any of the following conditions are true:
- 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)
- Inability to obtain CT angiograms for follow-up
- Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection
- 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 calcifications in the aortic arch as defined by CT angiography
- Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
- Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring \> 45mm in diameter
- Aortic arch aneurysm \> 45mm in diameter
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03397251
Start Date
March 7 2018
End Date
January 23 2024
Last Update
August 20 2024
Active Locations (1)
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1
Deutsches Hertzzentrum Berlin
Berlin, Germany, 13353