Status:
RECRUITING
Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Medtronic
Conditions:
Dissection of Thoracic Aorta
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending thoracic aortic pathologies including type A aortic dissection, who are suitable for endov...
Detailed Description
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies including type A aortic dissection, retrograde type A aortic dissection...
Eligibility Criteria
Inclusion
- In order to qualify for this physician-sponsored Investigational Device Exemption, the patients would have to meet the entire entry criteria listed below, sign a consent approved by the FDA and IRB, and agrees to follow-up according to the study protocol.
- Patient must have a type A thoracic aortic dissection, retrograde type A thoracic aortic dissection 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 a candidate for endovascular repair;
- The proximal and distal landing zones for placement of graft should be at least 1 cm.
- The proximal landing zone will allow placement of the stent graft as to not inhibit valvular function, occlude a coronary ostium or proximal bypass graft; The aortic root may be dissected, but the proximal tear site must be at least 1cm from the STJ (and within the above listed size criteria).
- Distal landing zone must allow for continued perfusion of critical cerebral vessels;
- The aorta as measured adventitial wall to adventitial wall must be greater than 28 mm and no more than 44 mm maximum diameter at both the proximal and distal landing zone.
- The patient must be high-risk surgical candidate according to the following established criteria: ASA score of 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 representative (LAR) who do not sign the informed consent;
- Patients with expected survival less than one year due to a condition other than the ascending aortic
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03322033
Start Date
December 15 2018
End Date
January 15 2028
Last Update
March 8 2022
Active Locations (1)
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1
Baylor Scott & White The Heart Hospital
Plano, Texas, United States, 75035