Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
ConditionAbdominal Aortic Aneurysms (AAA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBolton Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older at the time of consent
Life expectancy is greater than 2 years
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Fenestrated TREO Stent Graft System
DeviceThe 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Stage 1 - Roll-in ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
30-day post-procedure2
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
Time frame
12 months post-procedure3
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
Time frame
Evaluated 30-days post procedureSecondary outcomes
1
All-Cause Mortality
Individual component of the primary safety endpoint - defined as death due to any cause
Time frame
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.2
Myocardial Infarction (new onset)
Individual component of the primary safety endpoint - based on the SCAI definition
Time frame
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.3
Respiratory failure
Individual component of the primary safety endpoint - respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation
Time frame
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.4
Renal function decline
Individual component of the primary safety endpoint - Renal function decline resulting in \>50% reduction from baseline eGFR or new-onset dialysis
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov