Clinical trial NCT03322033: Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Official title: Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dissection of Thoracic Aorta
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).

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, who are suitable for endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with Dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft. For patients with type A aortic dissection, the investigators expect to reroute the blood to the true lumen by covering the proximal tear. In patients with retrograde type A aortic dissection, there might or might not be additional tears in the ascending aorta. If they are tears in ascending aorta, these dissections behave similarly like a type A aortic dissection, in which all the tears in the ascending aorta need to be covered. If the proximal tear is only in the descending thoracic aorta, these patients will require coverage in the ascending aorta with the stent graft along with coverage of proximal tear in the descending thoracic aorta using Valiant stent graft.

Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Freedom from early death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital
state: Texas
Study officials:
affiliation: Cardiac Surgery Specialists
name: William Brinkman, MD
role: PRINCIPAL_INVESTIGATOR
References: