Feasibility of Endovascular Repair of Ascending Aortic Pathologies

NCT03322033 | Terminated Results DMC FDA Device

• 1 other identifier: G170196
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Dissection of Thoracic Aorta

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Freedom From Early Death

  Number of participants with freedom from early death at 30-days post-procedure

  30 days

Study Arms (1)

Type A Dissection

EXPERIMENTAL

High risk subjects with ascending thoracic aortic pathologies including type A aortic dissection who are suitable for endovascular repair

Device: Valiant PS-IDE Stent Graft

Interventions

Valiant PS-IDE Stent Graft DEVICE

Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System

Type A Dissection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• Medtronic: collaborator

Study Sites (1)

Baylor Scott & White The Heart Hospital

Plano, Texas, 75035, United States

Location

MeSH Terms

Conditions

Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Results Point of Contact

• Title: Sarah Hale
• Organization: Baylor Scott and White Resarch Institute

sarah.hale@bswhealth.org

469-814-4845

Study Officials

• William Brinkman, MD

  Cardiac Surgery Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: December 15, 2018
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-01

Locations

US (1)