Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Part of paid clinical trials in Long Beach, California.

Sponsor
Rodney A. White, MD
Study ID
NCT02201589
Status
Recruiting
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Conditions

  • Aortic Dissection
  • Intramural Hematoma
  • Penetrating Ulcer
  • Pseudoaneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Nov 30, 2013
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endovascular repair of ascending aorta
    Endovascular repair with Valiant PS-IDE Stent Graft

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Long Beach Memorial Medical CenterLong BeachCalifornia90806
Rodney A White, MD
[email protected]
310.963.5230
Ali Khoynezhad, MD
[email protected]
310-498-2091
Rodney A. White, MD (PRINCIPAL_INVESTIGATOR)
Ali Khoynezhad, MD (PRINCIPAL_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
LAC Harbor-UCLA Medical CenterTorranceCalifornia90502
Rodney A White, MD (PRINCIPAL_INVESTIGATOR)
Ali Khoynezhad, M.D. PhD. (PRINCIPAL_INVESTIGATOR)

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