- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101463
MOSTEGRA TRIAL:MO-(Dified) STE-(nt) GRA(-ft): Surgeon-modified Fenestrated-branched Stent-grafts (MOSTEGRA)
Surgeon-Modified Fenestrated/Branched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Complex aortic aneurysms are those involving the renal and visceral arteries, and open repair of these aneurysms requires more extensive dissection, aortic clamping above the renal or mesenteric arteries, and possible reconstruction of aortic branches. Recovery time tends to be longer, including more hospital days, than for endovascular repair, and there is a greater potential for complications. Many high-risk patients with aneurysms of the abdominal aorta (AAA), including thoracoabdominal aortic aneurysms (TAAA), and significant co-morbidities will be denied elective open surgery because of heightened risks associated with open repair of complex aneurysms, and therefore, the potential benefit of an endovascular option increases as well.
Endovascular aneurysm repair has been shown to be an effective alternative in treating uncomplicated infrarenal and thoracic aneurysms in both the elective and urgent setting, yet there is limited experience with this technology in complex conditions. Fenestrated grafts have been developed as a minimally invasive treatment for patients with complex aortic aneurysms who are unfit for traditional open surgery.
Surgeon-modified fenestrated-branch stent grafts (sm-FBSG) with branches for the visceral vessels are custom-made by a qualified vascular surgeon for patients with complex aortic conditions. It is expected that they will minimize surgical risks and promote quicker recovery, and they could represent a therapeutic option for high-risk patients unfit for open surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30342
- Northside Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (abbreviated):
- Patients presenting for elective or urgent repair of a complex aortic aneurysm
- No other investigational agents or devices while on protocol
- Patient must be able and willing to comply with all follow-up exams
- Life expectancy of more than 1 year
- Patients with medical conditions that would make them unfit for open repair
Exclusion Criteria (abbreviated):
- Estimated life expectancy <1 year
- Contraindication to angiography
- Active infection
- Patients with ruptured or contained ruptured aortic aneurysm who are persistently hemodynamically unstable at the time of presentation
- Morbid Obesity with inability to visualize the aorta with available intraoperative imaging techniques
Anatomic exclusion criteria: iliac arteries and aorta must be able to accommodate endovascular devices and procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.
Time Frame: 30 Days
|
Major adverse events defined as:
The primary effectiveness endpoint is the proportion of treatment group subjects that achieve treatment success. Treatment success is a composite endpoint assessed at 12 months that includes successful delivery and deployment of the graft with branch vessel preservation (technical success) as well as freedom from Type 1 and 3 endoleaks, graft migration, and AAA enlargement or rupture. Technical success is defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved. Includes freedom from the following at 12 months: Type I & III endoleak, stent graft migration, AAA enlargement, AAA rupture and conversion to open repair through 12 months. |
30 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate postoperative all-cause morbidity after repair with sm-FBSG
Time Frame: >30 Days to 5 Years
|
|
>30 Days to 5 Years
|
Evaluate long-term survival and complications after repair of complex aortic aneurysms with sm-FBSG
Time Frame: >30 Days to 5 Years
|
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>30 Days to 5 Years
|
Successful device delivery and deployment with patency of all branches
Time Frame: 30 Days, 3 Months, 6 Months, and Years 1 to 5
|
|
30 Days, 3 Months, 6 Months, and Years 1 to 5
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Procedural / In-Hospital Evaluations
Time Frame: 30 Days
|
|
30 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph J. Ricotta, II, MD, MS, FACS, Northside Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSH 997
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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