Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 2013 |
| End Date: | December 2020 |
| Contact: | Rodney A White, M.D. |
| Email: | rawhite@ucla.edu |
| Phone: | 310 222-2704 |
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.
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.
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.
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.
We found this trial at
3
sites
Torrance, California 90502
Principal Investigator: Rodney A White, MD
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Ali Khoynezhad, MD, PhD
Phone: 310-423-3851
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Long Beach, California 90801
Principal Investigator: Rodney A. White, MD
Phone: 310-963-5230
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