Aortic DissectionNCT02201589
Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
A study testing Endovascular repair with Valiant PS-IDE Stent Graft in people with Aortic Dissection and Intramural Hematoma, run by Rodney A. White, MD at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection, Intramural Hematoma, Penetrating Ulcer
- What is being tested?
- Endovascular repair with Valiant PS-IDE Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to Dec 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Rodney A White, MD, 310.963.5230, rawhite@ucla.edu
Ali Khoynezhad, MD, 310-498-2091, akhoynezhad@memorialcare.org
- Terminated
Cedars Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
LAC Harbor-UCLA Medical Center
Torrance, California, 90502
Rodney A White, MD
Ali Khoynezhad, M.D. PhD.
About this study
Official title: Proposed Single Center Investigational Device Exemption: 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.
Read the 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.
- Being tested
- Endovascular repair with Valiant PS-IDE Stent Graft
- Keywords
- Lesions in the ascending thoracic aorta
- Medical subject headings
- Aortic Dissection, Penetrating Atherosclerotic Ulcer, Aneurysm, False
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular repair with Valiant PS-IDE Stent GraftDevice
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 group | Role | What they receive |
|---|---|---|
| Endovascular repair of ascending aorta | Experimental | Endovascular repair with Valiant PS-IDE Stent Graft Receives: Device: Endovascular repair with Valiant PS-IDE Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Successful deployment covering the entry tear, remodeling of lesion determined by serial CT scans and documentation of ruptures
Measured: To 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodney A. White, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodney A. White, MD, MemorialCare Health System
- Investigators
- Rodney A White, M.D., Principal investigator, LA BioMedical Research Institute at Harbor-UCLA Medical CenterAli Khoynezhad, M.D. PhD., Principal investigator, LA BioMedical Research Institute at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201589
- Sponsor's protocol ID
- PSIDE:Ascending Thoracic Aorta
- Status last verified
- May 2025
- First submitted
- 23 Jul 2014
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: share data at scientific meetings and publications