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NCT Number: NCT02201589

Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Memorial Medical Center, Long Beach, California, United States

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About this study

This is a prospective study with 20 patients planned to be enrolled. Patients who participate will be followed for 5 years after the surgery in which the stent graft was implanted. This will include the following schedule: A CT with and without contrast and echocardiogram 30 days after the Medtronic device is implanted, CT with and without contrast at 6 and 12 months post procedure and once a year from 2 years thru 5 years after the implant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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

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

    Time frame: Within 30 days of the index procedure

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

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

    Time frame: To 30 days

    Successful deployment covering the entry tear, remodeling of lesion determined by serial CT scans and documentation of ruptures

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Khoynezhad, M. D., PhD

CONTACT

[email protected]

310 423-3851

Rodney A White, M.D.

CONTACT

[email protected]

310 222-2704

Sponsors and collaborators

Lead sponsor

Rodney A. White, MD

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2028
Study completion
2033
First posted
Jul 28, 2014
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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