Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

NCT02201589 | Recruiting FDA Device

• 1 other identifier: PSIDE:Ascending Thoracic Aorta
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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) including type A aortic dissection, retrograde type A aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a condition where blood passes through the inner lining or between the layers of the blood vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type A aortic dissection is a condition where the dissection or tear in the ascending aorta starts from the descending aorta; an intramural hematoma is a collection of clotted blood within the aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and rupture causing injury or death. The plan for these patients is to repair the ascending thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery System. The Valiant Captivia has been evaluated worldwide and used extensively in patients with type B (descending) thoracic aortic dissection. Since the dissections in the ascending aortas mirror that of the descending aorta, it is expected that this stent graft will deliver similar performance and endurance in patients with type A aortic dissection. The investigators expect to reroute the blood to the true lumen (the inner space within the blood vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent graft is a stent frame made from Nitinol wire and covered with an expandable material made of a polyester material. This new study will determine how well the device works to treat dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending thoracic aorta.

Conditions

Aortic Dissection; Intramural Hematoma; Penetrating Ulcer; Pseudoaneurysm

Keywords

Lesions in the ascending thoracic aorta

Outcome Measures

Primary Outcomes (1)

• Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise

  Mortality, re-interventions, surgical conversions and post-procedure adverse events

  Within 30 days of the index procedure

Secondary Outcomes (1)

• A composite of successful delivery and deployment of stent graft, coverage of lesion and/or proximal entry tear, aortic remodeling based on serial imaging, rupture

  To 30 days

Study Arms (1)

Endovascular repair of ascending aorta

EXPERIMENTAL

Endovascular repair with Valiant PS-IDE Stent Graft

Device: Endovascular repair with Valiant PS-IDE Stent Graft

Interventions

Endovascular repair with Valiant PS-IDE Stent Graft DEVICE

Endovascular stent graft repair of lesions in the ascending thoracic aorta using the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft System with the Captivia Delivery System

Endovascular repair of ascending aorta

Eligibility Criteria

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

You may qualify if:

• 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.

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 representatives who do not sign the informed consent;
• Patients with expected survival less than one year.

Sponsors & Collaborators

• Rodney A. White, MD: lead

Study Sites (3)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

TERMINATED

LAC Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Penetrating Atherosclerotic Ulcer; Aneurysm, False

Condition Hierarchy (Ancestors)

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

Study Officials

• Rodney A White, M.D.

  LA BioMedical Research Institute at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Ali Khoynezhad, M.D. PhD.

  LA BioMedical Research Institute at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodney A White, M.D.

CONTACT

310 222-2704; rawhite@ucla.edu

Ali Khoynezhad, M. D., PhD

CONTACT

310 423-3851; ali.khoynezhad@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Vascular Surgery

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 28, 2014
• Study Start: November 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)