An interventional study of Endovascular repair with Valiant PS-IDE Stent Graft in Aortic Dissection, Intramural Hematoma and Penetrating Ulcer, sponsored by Rodney A. White, MD. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Rodney A. White, MD · Not applicable, Interventional, and Treatment
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.
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.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 20 is below the median of 114 across 86 interventional studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →Rodney A. White, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: Within 30 days of the index procedure
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
Successful deployment covering the entry tear, remodeling of lesion determined by serial CT scans and documentation of ruptures
Time frame: To 30 days
Not enrolling at this site.
Plan to share: No — share data at scientific meetings and publications
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Rodney A. White, MD