RECRUITING

Feasibility of Endovascular Repair of Ascending Aortic Pathologies

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies

Quick Facts

Study Start:2018-12-15

Study Completion:2028-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03322033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Megan C White, BA

CONTACT

469-814-4720

megan.white1@bswhealth.org

Principal Investigator

William Brinkman, MD

PRINCIPAL_INVESTIGATOR

Cardiac Surgery Specialists

Study Locations (Sites)

Baylor Scott & White The Heart Hospital

Plano, Texas, 75035

United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

William Brinkman, MD, PRINCIPAL_INVESTIGATOR, Cardiac Surgery Specialists

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-15

Study Completion Date2028-01-15

Study Record Updates

Study Start Date2018-12-15

Study Completion Date2028-01-15

Terms related to this study

Additional Relevant MeSH Terms

Dissection of Thoracic Aorta