MOSTEGRA TRIAL:MO-(Dified) STE-(nt) GRA(-ft): Surgeon-modified Fenestrated-branched Stent-grafts
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2012 |
| End Date: | December 2022 |
| Contact: | Margie Wong, MBA, BSN, RN, CCRC |
| Email: | margaret.wong@northside.com |
| Phone: | (404) 236-8305 |
Surgeon-Modified Fenestrated/Branched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for
Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting
period by a qualified vascular surgeon. In addition, it aims to examine the alternative
sm-FBSG for patients with restricted access to centers performing clinical trials with
commercially available devices and those patients with aortic emergencies.
Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting
period by a qualified vascular surgeon. In addition, it aims to examine the alternative
sm-FBSG for patients with restricted access to centers performing clinical trials with
commercially available devices and those patients with aortic emergencies.
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.
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.
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
We found this trial at
1
site
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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