Complex Aortic AneurysmsMOSTEGRANCT02101463
MOSTEGRA TRIAL:MO-(Dified) STE-(nt) GRA(-ft): Surgeon-modified Fenestrated-branched Stent-grafts
A study testing surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) in people with Complex Aortic Aneurysms, run by Northside Hospital, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Aortic Aneurysms
- What is being tested?
- surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2012to 8 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)
- Keywords
- aortic, sm-FBSG, aneurysms, fenestrated, stent-grafts, Vascular, Endovascular
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)Device
| Study group | Role | What they receive |
|---|---|---|
| surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) | Other | Not described Receives: Device: surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.
Major adverse events defined as:
- All-cause death
- Bowel ischemia
- Myocardial infarction
- Paraplegia
- Renal failure
- Respiratory failure
- Stroke
- Blood loss >=1,000cc
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.
Measured: 30 Days
Secondary outcomes (4)
Evaluate postoperative all-cause morbidity after repair with sm-FBSG
- Need for open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft for any reason
- Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
- Organ dysfunction
Measured: >30 Days to 5 Years
Evaluate long-term survival and complications after repair of complex aortic aneurysms with sm-FBSG
- Examination of Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
- Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak, device migration, or other device defect.
- Clinical evaluation and changes over time.
Measured: >30 Days to 5 Years
Successful device delivery and deployment with patency of all branches
- Change in aneurysm sac diameter from the first post-procedural measurement; incidence of endoleak, device migration, or limb occlusion
- Fenestrated stent graft patent luminal flow; absence of stent fracture or graft fatigue/failure
- Renal and/or Mesenteric Artery and Stent Patency and Integrity
Measured: 30 Days, 3 Months, 6 Months, and Years 1 to 5
Procedural / In-Hospital Evaluations
- Organ Perfusion and Function
- Distal blood flow
- Fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time; ICU time; time to hospital discharge
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start28 Aug 2012
- Primary completion31 Jul 2015
- Study completion8 Dec 2015
Why it stopped: Principal Investigator left the organization and took the IDE/Study with him
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph J. Ricotta, II, MD, MS, FACS, Principal investigator, Northside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101463
- Sponsor's protocol ID
- NSH 997
- Acronym
- MOSTEGRA
- Status last verified
- Nov 2019
- First submitted
- 25 Mar 2014
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon-Modified Fenestrated/Branched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
- ClinicalTrials.gov ID
- NCT02101463
- Acronym / sponsor ID
- MOSTEGRA / NSH 997
- Conditions
- Complex Aortic Aneurysms
- Keywords
- aortic, sm-FBSG, aneurysms, fenestrated, stent-grafts, Vascular, Endovascular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the organization and took the IDE/Study with him
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northside Hospital, Inc.University, hospital or other
- Study start
- 28 Aug 2012 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 8 Dec 2015 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) | Other | Device: surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) | Device | surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) |
Primary outcome
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: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss >=1,000cc 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.
4 secondary outcomes
Evaluate postoperative all-cause morbidity after repair with sm-FBSG
Time frame: >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
Successful device delivery and deployment with patency of all branches
Time frame: 30 Days, 3 Months, 6 Months, and Years 1 to 5
Procedural / In-Hospital Evaluations
Time frame: 30 Days
Results and safety
The study was stopped early (reason given: Principal Investigator left the organization and took the IDE/Study with him). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Northside Vascular WebsiteLink provided by the sponsor.
Related trials for Complex Aortic Aneurysms
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
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Recruiting
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
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RecruitingObservational study
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
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European Aortic Data Collection Project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph J. Ricotta, II, MD, MS, FACS principal investigator
Northside Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) in people with Complex Aortic Aneurysms, run by Northside Hospital, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator left the organization and took the IDE/Study with him). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.