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Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

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ClinicalTrials.gov Identifier: NCT02201589
Recruitment Status : Recruiting
First Posted : July 28, 2014
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Rodney A. White, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Intramural Hematoma Penetrating Ulcer Pseudoaneurysm Device: Endovascular repair with Valiant PS-IDE Stent Graft Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
Study Start Date : September 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Endovascular repair of ascending aorta
Endovascular repair with Valiant PS-IDE Stent Graft
Device: Endovascular repair with Valiant PS-IDE Stent Graft
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 Outcome Measures :
  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 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201589


Contacts
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Contact: Rodney A White, M.D. 310 222-2704 rawhite@ucla.edu
Contact: Ali Khoynezhad, M. D., PhD 310 423-3851 ali.khoynezhad@cshs.org

Locations
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United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Rodney A White, MD    310-963-5230    rawhite@ucla.edu   
Contact: Ali Khoynezhad, MD    310-498-2091    akhoynezhad@memorialcare.org   
Principal Investigator: Rodney A. White, MD         
Principal Investigator: Ali Khoynezhad, MD         
Cedars Sinai Medical Center Terminated
Los Angeles, California, United States, 90048
LAC Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Principal Investigator: Rodney A White, MD         
Principal Investigator: Ali Khoynezhad, M.D. PhD.         
Sponsors and Collaborators
Rodney A. White, M.D.
Investigators
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Principal Investigator: 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

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Responsible Party: Rodney A. White, M.D., Chief, Vascular Surgery, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT02201589     History of Changes
Other Study ID Numbers: PSIDE:Ascending Thoracic Aorta
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rodney A. White, M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Lesions in the ascending thoracic aorta
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm, False
Hematoma
Hemorrhage
Pathologic Processes
Aneurysm
Vascular Diseases
Cardiovascular Diseases