Clinical trial NCT02101463: MOSTEGRA TRIAL:MO-(Dified) STE-(nt) GRA(-ft): Surgeon-modified Fenestrated-branched Stent-grafts
Official title: Surgeon-Modified Fenestrated/Branched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complex Aortic Aneurysms
Keywords: aortic
sm-FBSG
aneurysms
fenestrated
stent-grafts
Vascular
Endovascular
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.
timeFrame: 30 Days
Secondary outcomes:
measure: Evaluate postoperative all-cause morbidity after repair with sm-FBSG
timeFrame: >30 Days to 5 Years
measure: Evaluate long-term survival and complications after repair of complex aortic aneurysms with sm-FBSG
timeFrame: >30 Days to 5 Years
measure: Successful device delivery and deployment with patency of all branches
timeFrame: 30 Days, 3 Months, 6 Months, and Years 1 to 5
measure: Procedural / In-Hospital Evaluations
timeFrame: 30 Days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Northside Hospital
name: Joseph J. Ricotta, II, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: