MOSTEGRA TRIAL:MO-(Dified) STE-(nt) GRA(-ft): Surgeon-modified Fenestrated-branched Stent-grafts

NCT ID: NCT02101463

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-28
• Study Completion Date: 2015-12-08

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.

Conditions

Complex Aortic Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

Group Type: OTHER

surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

Intervention Type: DEVICE

Interventions

surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northside Hospital, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph J. Ricotta, II, MD, MS, FACS

Role: PRINCIPAL_INVESTIGATOR

Northside Hospital

Locations

Northside Hospital

Atlanta, Georgia, United States

Countries

United States

Related Links

http://www.nvs-ga.com/

Northside Vascular Website

Other Identifiers

NSH 997

Identifier Type: -

Identifier Source: org_study_id