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NCT02201589 · ClinicalTrials.gov registry record · NA
Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
A NA study of Aortic Dissection and Intramural Hematoma, sponsored by Rodney A. White, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT02201589 is a NA study of Aortic Dissection and Intramural Hematoma that is actively recruiting participants, run by Rodney A. White, MD. The registered enrollment target is 20 participants, below the 662-participant average among 11 other Aortic Dissection trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT02201589, a NA study of Aortic Dissection and Intramural Hematoma, is actively recruiting participants, sponsored by Rodney A. White, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study 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
Conditions Studied
Interventions
- DEVICE Endovascular repair with Valiant PS-IDE Stent Graft
Study Locations (3)
California
- Long Beach Memorial Medical Center - Long Beach
- Cedars Sinai Medical Center - Los Angeles
- LAC Harbor-UCLA Medical Center - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-11 |
| Est. Completion | 2033-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02201589
The ClinicalTrials.gov registry entry for NCT02201589 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 662-participant average among 11 other Aortic Dissection trials with a reported enrollment target (97% lower). The listed sponsor is Rodney A. White, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Aortic Dissection appearing as the primary indexed condition, and to 1 intervention - of which Endovascular repair with Valiant PS-IDE Stent Graft is the first listed.
NCT02201589 reports 3 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02201589 about?
NCT02201589 is a clinical study titled "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...
What is the current status of trial NCT02201589?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2013-11. Estimated completion is 2033-12.
What conditions does trial NCT02201589 study?
This clinical trial studies the following conditions: Aortic Dissection, Intramural Hematoma, Pseudoaneurysm, Penetrating Ulcer.
What interventions are being tested in trial NCT02201589?
The interventions under investigation include: Endovascular repair with Valiant PS-IDE Stent Graft (DEVICE).
Who is sponsoring clinical trial NCT02201589?
This trial is sponsored by Rodney A. White, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02201589 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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