Abdominal Aortic Aneurysms (AAA)NCT07026877
Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
A study testing Fenestrated TREO Stent Graft System in people with Abdominal Aortic Aneurysms (AAA), run by Bolton Medical at 7 sites in United States.
Trial summary
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- What is being tested?
- Fenestrated TREO Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Nov 2025to 29 May 2030
- Phase
- Interventional
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
- 18 years or older at the time of consent
- Life expectancy is greater than 2 years
- An abdominal aortic or aorto-iliac aneurysm requiring a fenestrated graft and with morphology suitable for endovascular repair (confirmed by Computed Tomography (CT) with contrast performed within 6 months of planned implant procedure) as follows:
- Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
- Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
- Aneurysm with a history of growth > 0.5 cm in 6 months and
Show all 26Show fewer
- Minimum 0 mm of healthy aorta* below the most inferior renal artery that the physician plans on preserving and no renal artery involvement (juxtarenal aneurysms) or
- At least one renal artery involved in the aneurysm and minimum 2 mm below the celiac (suprarenal aneurysms) *Healthy aorta is defined as segment of aorta with parallel aortic wall with minimal (<10%) or no difference in diameter and minimal atherosclerotic debris, thrombus, or calcification.
- Proximal landing zone:
- ≥20 mm length
- 20-32 mm diameter
- ≤60° angle relative to the axis of the suprarenal aorta
- ≤60° angle relative to the long axis of the aneurysm
- Distal (iliac) landing zone with:
- 8-13 mm inside diameter/ ≥10 mm length
- >13-20 mm inside diameter/ ≥15 mm length
- Distal aortic diameter (above the iliac bifurcation) ≥70% of the sum of the iliac limb graft diameters
- Minimum 18 mm aortic lumen diameter at the level of the fenestrations
- Pathology that requires maximum 5 fenestrations in the main body
- Pathology that requires fenestration a minimum 3 mm apart (edge to edge)
- Branch vessels (to be bridged to the fenestrated graft) with:
- 5-9 mm diameters
- ≥13 mm distal landing zone (or ≥15 mm if there is a gap between fenestration and target vessel)
- Adequate renal function to tolerate contrast-enhanced CTA
- Adequate vascular access compatible with required delivery systems
- Willingness to comply with the follow-up evaluation schedule documented in a signed informed consent prior to implant
Who cannot join
- Pregnant or lactating
- Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System
- Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
- Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.
- A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with bridging stent delivery or sealing (as determined by treating physician)
- Severe untreated coronary artery disease and/or unstable angina, significant areas of myocardium at risk (based on coronary angiogram or radionuclide scans), left ventricular ejection fraction <20%, or recent diagnosis of congestive heart failure (CHF; as determined by treating physician).
Show all 24Show fewer
- Stroke or myocardial infarction within 6 months of the planned treatment date
- Chronic obstructive pulmonary disease requiring routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use)
- Chronic Kidney Disease (CKD) stage ≥3b.*
- During Stage 2, patients with severe CKD (stage ≥3b) can be included in the Expanded Access Arm if otherwise eligible.
- Active systemic infection or is suspected of having an active systemic infection (e.g., acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV), sepsis)
- Clinical conditions that would severely compromise or impair x-ray visualization of the aorta (as determined by treating physician).
- History of an aortopathic connective tissue disease (e.g., Marfan's syndrome)
- Mycotic aneurysm
- Significant or circumferential calcification or mural thrombus (as determined by treating physician):
- in the proximal aortic neck
- in the distal iliac landing zone
- within the treatment length, which may adversely impact device patency
- Cannot receive intraprocedural anticoagulation per the investigator's standard of care, or antiplatelet therapy post-procedurally as per the investigator's standard of care.
- Blood coagulation disorder or bleeding diathesis, the treatment for which cannot be suspended pre- and post-repair
- An investigational study drug or biologic within 30 days of planned procedure or an investigational device within one year of planned procedure or any other treatment that may interfere with the interpretation of the study results.
- Medical, social or psychological issues that the investigator believes may interfere with study treatment or follow-up.
- Untreatable allergy or sensitivity to contrast media, nitinol/nickel, Tantalum, Platinum Iridium (PtIr), 316 stainless steel, ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene) Impregnated polyester fiber, or polyester
- Other major surgical or medical intervention within 45 days of the planned procedure or plan to undergo other major surgical or medical intervention within 45 days post implantation (e.g., coronary artery bypass graft (CABG), organ transplantation, renal stenting)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 5 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Omar Selim
Omar Selim
- Recruiting
UC Health Memorial
Colorado Springs, Colorado, 80909
Melhelm Sharafuddin
Melhelm Sharafuddin
- Active, not recruiting
Mt. Sinai
New York, New York, 10019
- Active, not recruiting
Baylor Scott and White Research Institute
Plano, Texas, 75093
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Sara Zettervall
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
John Ohman, 314-273-1296, ohmanj@wustl.edu
- Not yet recruiting
Tampa General Hospital
Tampa, Florida, 33606
Dean Arnaoutakis, arnaoutakis@usf.edu
About this study
Official title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System.
The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm?
Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Being tested
- Fenestrated TREO Stent Graft System
- Keywords
- Abdominal Aortic Aneurysm, juxtarenal, endovascular
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestrated TREO Stent Graft SystemDevice
The Fenestrated TREO Stent-Graft System is a modular, endoluminal, over-the-wire system intended for the endovascular treatment of juxtarenal and pararenal to paravisceral aneurysms requiring a fenestrated stent-graft and having suitable morphology. The system is composed of the following components:
Fenestrated TREO Bifurcate Stent-Graft - The main body fenestrated bifurcate provides the following; proximal seal, fenestrations and gates for connection to the leg extensions.
Bridging Stents - The bridging stent connects the main body bifurcated device to the target visceral artery allowing the target anatomy to maintain perfusion while keeping the pathology sealed
TREO Leg and Straight Extension Stent-Grafts: The Leg Extension and Straight Extension stent-grafts are used to complete coverage of the pathology from the main body bifurcated device to the distal landing zones (usually the common iliac artery just proximal to the iliac bifurcation).
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - Roll-in Arm | Experimental | Minimum of 20 subjects (up to 30) with juxtarenal Abdominal Aortic Aneurysm (AAA), being treated with the Fenestrated TREO Stent-Graft System Receives: Device: Fenestrated TREO Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with absence of a major adverse event (Primary Safety Endpoint)
The primary safety endpoint is the absence of a major adverse event (MAE) at 30-day post procedure.
MAEs are defined as follows:
- All-cause mortality, defined as death due to any cause
- Myocardial infarction (new onset) based on the Society for Cardiovascular Angiography \& Interventions (SCAI) definition
- Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation
- Renal function decline resulting in >50% reduction from baseline estimated glomerular filtration rate (eGFR) or new-onset dialysis
- Bowel ischemia requiring surgical resection or not resolving with medical therapy
- Disabling stroke (modified Rankin Scale (mRS) score ≥2 at 90 days post event and an increase in ≥1 mRS category from an individual's pre-stroke baseline, as direct result of the neurological event)
- Paraplegia (grade 3, Society for Vascular Surgery (SVS) Thoracic Endovascular Aortic Repair (TEVAR) guidelines)
Measured: 30-day post-procedure
Proportion of patients with successful aneurysm treatment through 12-months post-implant procedure (Primary Effectiveness Endpoint)
The primary effectiveness endpoint is the proportion of patients with successful aneurysm treatment through 12-months post-implant procedure, which is a composite of technical success and absence of the following:
- Aneurysm-related mortality: Death occurs within the first 30-days of the index procedure or a secondary intervention, OR any death that results from aneurysm rupture or an aorta-related complication (e.g., implant infection, occlusion, dissection)
- Aneurysm rupture: Rupture of the native aneurysm sac (treated lesion)
- Type I/III Endoleak
- Aneurysm Expansion (>5 mm)
- Migration (>10 mm)
- Loss of patency (i.e., complete occlusion of the aortic implant and/or bridging stent(s))
- Conversion to open surgical repair: Explant of the investigational device due to any cause
- Secondary intervention (clinically significant) to address loss of patency, fixation or seal
Measured: 12 months post-procedure
Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components (Technical Success)
Composite:
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduit without the need for unanticipated corrective intervention related to access
- Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components without the need for unanticipated corrective intervention related to delivery and deployment
- Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels without the need for unanticipated corrective intervention related to placement of the bridging stent(s)
- Successful withdrawal of the delivery systems without the need for unanticipated corrective intervention related to withdrawal
- Absence of Type I or III endoleaks (assessed by Computed Tomography Angiography, Magnetic Resonance Angiography, or duplex ultrasound)
- Patency of all aortic modular stent graft components
Measured: Evaluated 30-days post procedure
Secondary outcomes (31)
All-Cause Mortality
Individual component of the primary safety endpoint - defined as death due to any cause
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Myocardial Infarction (new onset)
Individual component of the primary safety endpoint - based on the SCAI definition
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Respiratory failure
Individual component of the primary safety endpoint - respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Renal function decline
Individual component of the primary safety endpoint - Renal function decline resulting in >50% reduction from baseline eGFR or new-onset dialysis
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Bowel ischemia
Individual component of the primary safety endpoint - Bowel ischemia requiring surgical resection or not resolving with medical therapy
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Disabling stroke
Individual component of the primary safety endpoint - Disabling stroke (mRS score ≥2 at 90 days post event and an increase in ≥1 mRS category from an individual's pre-stroke baseline, as direct result of the neurological event)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Paraplegia
Individual component of the primary safety endpoint -Paraplegia grade 3, as per SVS TEVAR guidelines
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Aneurysm-related mortality
Individual components of the primary effectiveness endpoint - defined as death which occurs within the first 30-days of the index procedure or a secondary intervention, OR any death that results from aneurysm rupture or an aorta-related complication (e.g., implant infection, occlusion, dissection)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Aneurysm rupture
Individual components of the primary effectiveness endpoint - Rupture of the native aneurysm sac (treated lesion)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Type I/III Endoleak
Individual components of the primary effectiveness endpoint - Presence of Type I/IIIEndoleak as confirmed by imaging
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Aneurysm Expansion
Individual components of the primary effectiveness endpoint - Aneurysm expansion (>5 mm)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Device Migration
Individual components of the primary effectiveness endpoint - Device migration (>10mm)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Loss of device patency
Individual components of the primary effectiveness endpoint - complete occlusion of the aortic implant and/or bridging stent(s)
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Conversion to open surgical repair
Individual components of the primary effectiveness endpoint - Explant of the investigational device due to any cause
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Secondary intervention (clinically significant) to address loss of patency, fixation or seal
Individual components of the primary effectiveness endpoint. This includes the following reasons for re-intervention:
Loss of Patency: Complete occlusion of the aortic endovascular graft, bridging stent(s), and/or limb(s) Seal: Type Ia/Ib, IIIa/IIIb/IIIc Endoleaks Fixation: Fracture, Kink, Migration Device System Prophylaxis: Device-related Reintervention requiring hospitalization
Minor Secondary Interventions will not count against the endpoint and include the following:
Endovascular procedures (completed for any reason), specifically percutaneous transluminal angioplasty, atherectomy, stenting without thrombectomy or thrombolysis Interventions to address branch vessel stenosis Interventions to address Type II endoleaks Minor surgical revisions (e.g., patch angioplasty) of the access vessel
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Technical Success (at the index procedure)
Technical Success (at the index procedure) is a composite of the following:
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduit without the need for unanticipated corrective intervention related to access.
- Successful delivery and deployment of the aortic stent-graft and all modular stent-graft components without the need for unanticipated corrective intervention related to delivery and deployment.
- Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels without the need for unanticipated corrective intervention related to placement of the bridging stent(s)
- Successful withdrawal of the delivery systems without the need for unanticipated corrective intervention related to withdrawal.
Measured: At time of index procedure
Presence of endoleak
Evaluation of the presence of all endoleak types, as confirmed by imaging
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Aneurysm size changes
Evaluation of changes in aneurysm size. Enlargement is defined as >5mm, regression is ≥ 5 mm.
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Device Migration Evaluation
Evaluation of device migration. Migration is defined as >10mm.
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Patency related observations
Stenosis and occlusion of the components of the Fenestrated TREO Stent-Graft System
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Loss of device integrity
Fracture of stent strut, barb, or fenestration ring in Fenestrated TREO, fracture of stent in any Fenestrated TREO system implant
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Target vessel instability
Target vessel instability is a composite endpoint consisting of the following side branch complications:
- Death related to side branch complication(s)
- Rupture related to side branch complication(s)
- Secondary intervention to address a side branch-related complication
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Secondary interventions related to the device/treated lesion
Any secondary interventions that are performed that are related to the device or the treated lesion will be recorded.
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Target vessel complications
Including dissection and/or perforation
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Access-related complications
Access-related complications
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Serious Adverse Events
As per protocol definition
Measured: Evaluated at all follow up visits which occur at the following timepoints: at discharge, 30 days post-procedure, six months post-procedure, 12-months post-procedure and annually thereafter through to five years post-procedure.
Operative metrics - Time
Information relating to the time of the surgical procedure such as start time, stop time, duration of procedure (min) and length of endovascular time (min)
Measured: Perioperative
Operative metrics - Number of Vessels intended to be Perfused via Fenestrated TREO Fenestrations
Information relating to the number and name of the vessels to be perfused via the Fenestrated TREO Fenestrations
Measured: Evaluated at time of implant
Operative metrics - Mechanism of access
Information relating to the mechanism of access for the endovascular procedure
Measured: Evaluated at time of implant
Radiation Exposure - Fluoroscopy Time
Fluoroscopy time (min)
Measured: Evaluated at time of implant
Radiation Exposure - Total volume of Contrast
Volume of contrast used during procedure measured in mL
Measured: Evaluated at time of implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start18 Nov 2025
- Primary completion29 May 2027 (estimated)
- Study completion29 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin W Starnes, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026877
- Sponsor's protocol ID
- IP-0022-24
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Publications and presentations referring to the study will be coordinated by a Study Publication Committee overseen by the Sponsor. This committee will be responsible for the following activities: determining the scope of each publication; reviewing data provided by the Biostatistician; writing scientific papers or preparing presentation; submitting papers for publication or abstracts for conference/congress presentations. Decisions on IPD sharing will be taken as part of the study publication process.
Publications
Starnes BW, Zettervall S, Larimore A, Singh N. Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms. Ann Surg. 2024 Oct 1;280(4):633-639. doi: 10.1097/SLA.0000000000006422. Epub 2024 Jun 26.
PubMed 38920026Tinelli G, Sica S, Sobocinski J, Ribreau Z, de Waure C, Ferraresi M, Snider F, Tshomba Y, Haulon S. Long-Term Propensity-Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair of Complex Abdominal Aortic Aneurysms. J Endovasc Ther. 2024 Dec;31(6):1208-1217. doi: 10.1177/15266028231162256. Epub 2023 Mar 28.
PubMed 36978269Deery SE, Lancaster RT, Baril DT, Indes JE, Bertges DJ, Conrad MF, Cambria RP, Patel VI. Contemporary outcomes of open complex abdominal aortic aneurysm repair. J Vasc Surg. 2016 May;63(5):1195-200. doi: 10.1016/j.jvs.2015.12.038.
PubMed 27109792Locham S, Dakour-Aridi H, Bhela J, Nejim B, Bhavana Challa A, Malas M. Thirty-Day Outcomes of Fenestrated and Chimney Endovascular Repair and Open Repair of Juxtarenal, Pararenal, and Suprarenal Abdominal Aortic Aneurysms Using National Surgical Quality Initiative Program Database (2012-2016). Vasc Endovascular Surg. 2019 Apr;53(3):189-198. doi: 10.1177/1538574418819284. Epub 2018 Dec 26.
PubMed 30587096Meuli L, Kaufmann YL, Lattmann T, Attigah N, Dick F, Mujagic E, Papazoglou DD, Weiss S, Wyss TR, Zimmermann A. Editor's Choice - Peri-operative Mortality and Morbidity of Complex Abdominal Aortic Aneurysm Repair in Switzerland: A Swissvasc Report. Eur J Vasc Endovasc Surg. 2025 Jan;69(1):25-35. doi: 10.1016/j.ejvs.2024.06.022. Epub 2024 Jun 19.
PubMed 38906370Latz CA, Boitano L, Schwartz S, Swerdlow N, Dansey K, Varkevisser RRB, Patel V, Schermerhorn ML. Editor's Choice - Mortality is High Following Elective Open Repair of Complex Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2021 Jan;61(1):90-97. doi: 10.1016/j.ejvs.2020.09.002. Epub 2020 Oct 9.
PubMed 33046385Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19.
PubMed 26100447Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, Kurella Tamura M, Feldman HI. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014 May;63(5):713-35. doi: 10.1053/j.ajkd.2014.01.416. Epub 2014 Mar 16.
PubMed 24647050Vaidya SR, Aeddula NR. Chronic Renal Failure. In: StatPearls. Treasure Island (FL): StatPearls Publishing, http://www.ncbi.nlm.nih.gov/books/NBK535404/ (2023, accessed 18 September 2023)
Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. doi: 10.1016/j.jacc.2013.08.720.
PubMed 24135581Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL; Society for Vascular Surgery Ad Hoc Committee on TEVAR Reporting Standards. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg. 2010 Oct;52(4):1022-33, 1033.e15. doi: 10.1016/j.jvs.2010.07.008. No abstract available.
PubMed 20888533Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, Matsumura JS, May J, Veith FJ, Fillinger MF, Rutherford RB, Kent KC; Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002 May;35(5):1048-60. doi: 10.1067/mva.2002.123763. No abstract available.
PubMed 12021727Zettervall SL, Starnes BW. Planning and sizing of fenestrated/branched stent grafts. Semin Vasc Surg. 2022 Sep;35(3):252-258. doi: 10.1053/j.semvascsurg.2022.07.006. Epub 2022 Aug 6.
PubMed 36153066Lott A, Reiter JP. Wilson Confidence Intervals for Binomial Proportions With Multiple Imputation for Missing Data. The American Statistician 2020; 74: 109-115.
Raulli SJ, Gomes VC, Parodi FE, Vasan P, Sun D, Marston WA, Pascarella L, McGinigle KL, Wood JC, Farber MA. Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent. J Vasc Surg. 2024 Aug;80(2):302-310. doi: 10.1016/j.jvs.2024.04.017. Epub 2024 Apr 10.
PubMed 38608964