Endovascular repair for ascending aortic conditions
Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies
This study is testing if a special stent can safely repair problems in the ascending aorta for patients with conditions like aortic dissection and pseudoaneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MemorialCare Health System Academic / other |
| Locations | 3 sites (Long Beach, California and 2 other locations) |
| Trial ID | NCT02201589 on ClinicalTrials.gov |
What this trial studies
This study investigates the outcomes of patients with various pathologies of the ascending thoracic aorta, including type A aortic dissection and pseudoaneurysms, who are suitable for endovascular repair using the Medtronic Valiant PS-IDE Stent Graft. A total of 20 patients will be enrolled and followed for five years post-surgery. Participants will undergo a series of imaging tests, including CT scans and echocardiograms, to monitor their condition and the effectiveness of the stent graft over time.
Who should consider this trial
Good fit: Ideal candidates include high-risk surgical patients with specific aortic pathologies affecting the ascending thoracic aorta who meet the inclusion criteria.
Not a fit: Patients who are pregnant, pediatric, or have conditions that could lead to infection of the stent graft will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with serious aortic conditions, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promise with endovascular approaches for aortic conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Long Beach, California and 2 other locations
- Long Beach Memorial Medical Center — Long Beach, California, United States (Recruiting)
- Cedars Sinai Medical Center — Los Angeles, California, United States (Terminated)
- LAC Harbor-UCLA Medical Center — Torrance, California, United States (Recruiting)
Study contacts
- Principal investigator: Rodney A White, M.D. — LA BioMedical Research Institute at Harbor-UCLA Medical Center
- Study coordinator: Rodney A White, M.D.
- Email: rawhite@ucla.edu
- Phone: 310 222-2704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.