Status:
RECRUITING
Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
Lead Sponsor:
Rodney A. White, MD
Conditions:
Aortic Dissection
Intramural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the outcome of patients with pathologies of the ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from the heart) inclu...
Detailed Description
This is a prospective study with 20 patients planned to be enrolled. Patients who participate will be followed for 5 years after the surgery in which the stent graft was implanted. This will include t...
Eligibility Criteria
Inclusion
- Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair;
- Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter;
- The patient must be deemed high-risk surgical candidate according to the following established criteria: ASA (American Society of Anesthesiologists) class IV.
Exclusion
- Pregnant or pediatric patients (younger than 21 years of age);
- Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis;
- Patients with allergies to the stent graft material;
- Patients or their legally authorized representatives who do not sign the informed consent;
- Patients with expected survival less than one year.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02201589
Start Date
November 1 2013
End Date
December 1 2033
Last Update
May 6 2025
Active Locations (3)
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1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
LAC Harbor-UCLA Medical Center
Torrance, California, United States, 90502