Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Aortic Dissection Clinical Trial

Official title:

Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02201589
• Other study ID #: PSIDE:Ascending Thoracic Aorta
• Status: Recruiting
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2030

Study information

• Verified date: December 2023
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: Rodney A White, M.D.
• Phone: 310 222-2704
• Email: rawhite[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Hematoma
• Intramural Hematoma
• Penetrating Ulcer
• Pseudoaneurysm

Intervention

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

Locations

Country	Name	City	State
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	LAC Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Rodney A. White, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days of the index procedure
Secondary	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	To 30 days