Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03322033
Status:
RECRUITING
Last Update Posted:
2022-03-08
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PS-IDE
Brief Summary:
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending thoracic aortic pathologies including type A aortic dissection, who are suitable for endovascular repair with the Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System (or the Valiant PS-IDE Stent Graft).
Detailed Description:
The purpose of this early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies including type A aortic dissection, retrograde type A aortic dissection, who are suitable for endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with Dissections affecting the aorta between the Sinus of Valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft. For patients with type A aortic dissection, the investigators expect to reroute the blood to the true lumen by covering the proximal tear. In patients with retrograde type A aortic dissection, there might or might not be additional tears in the ascending aorta. If they are tears in ascending aorta, these dissections behave similarly like a type A aortic dissection, in which all the tears in the ascending aorta need to be covered. If the proximal tear is only in the descending thoracic aorta, these patients will require coverage in the ascending aorta with the stent graft along with coverage of proximal tear in the descending thoracic aorta using Valiant stent graft.
Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.
Patients will be selected from a high-risk surgical cohort. The total number of enrolled subjects is planned to be 20.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: