- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393716
Endurant Evo US Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92123
- Kaiser Permanente Zion Medical Center
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Stanford, California, United States, 94305-5330
- Stanford Hospital & Clinics
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District of Columbia
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Washington, District of Columbia, United States, 20010-3017
- Medstar Heart & Vascular Institute
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Maine
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Portland, Maine, United States, 04102-3134
- Maine Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02215-5324
- Beth Israel Deaconess Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health Sysem
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New York
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New Hyde Park, New York, United States, 11040
- Long Island Jewish Northshore University Hospital
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Ohio
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Cincinnati, Ohio, United States, 45219-2906
- The Christ Hospital
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17101-2010
- UPMC Pinnacle Harrisburg Campus
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Tennessee
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Chattanooga, Tennessee, United States, 37403-2147
- Erlanger Medical Center
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Texas
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Austin, Texas, United States, 78756-4080
- Heart Hospital of Austin
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Washington
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Spokane, Washington, United States, 99204-2307
- Providence Sacred Heart Medical Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215-3669
- Aurora St. Lukes Medial Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is ≥18 years old
- Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
- Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of flow)
- Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging:
- Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
- Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
- Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm
- The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifurcation and unilaterally for the Aorto-uni-iliac stent graft (AUI)
- Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system
- Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifurcation and unilaterally for the AUI
Exclusion Criteria:
- Subject has a life expectancy ≤1 year
- Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- Subject is pregnant
Subject has an aneurysm that is:
- Suprarenal/pararenal/juxtarenal
- Isolated ilio-femoral
- Mycotic
- Inflammatory
- Pseudoaneurysm
- Dissecting
- Ruptured
- Leaking but not ruptured
- Subject requires emergent aneurysm treatment
- Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
- Subject has been previously treated for an abdominal aortic aneurysm
- Subject has a history of bleeding diathesis or coagulopathy
- Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft
- Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
- Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
- Subject has a known allergy or intolerance to the device materials
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
- Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator
- Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
- Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or tortuosity
- Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
- Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion
- Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
- Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)
- Subject is on dialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Endovascular repair
Endurant Evo AAA Stent Graft System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
Time Frame: 30-days
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The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events:
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30-days
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The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Time Frame: 12-months
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Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from:
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12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause Mortality
Time Frame: within 30, 183, and 365 days
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All-cause mortality (ACM) within 30, 183, 365 days
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within 30, 183, and 365 days
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Aneurysm-related Mortality (ARM)
Time Frame: within 30, 183, and 365 days
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Aneurysm-related mortality (ARM) within 30, 183, and 365 days
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within 30, 183, and 365 days
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Secondary Procedures to Correct Type I and III Endoleaks
Time Frame: within 183, and 365 days
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Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days.
Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.
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within 183, and 365 days
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Secondary Procedures
Time Frame: within 183, and 365 days
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Secondary procedures within 183 and 365 days
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within 183, and 365 days
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Serious Adverse Events
Time Frame: within 30, 183, and 365 days
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Serious adverse events within 30, 183 and 365 days.
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within 30, 183, and 365 days
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Conversion to Open Surgery
Time Frame: within 183, and 365 days
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Conversion to open surgery within 183, and 365 days
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within 183, and 365 days
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Aneurysm Rupture
Time Frame: within 183 and 365 days
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Aneurysm rupture within 183 and 365 days
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within 183 and 365 days
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Major Adverse Events
Time Frame: within 183 and 365 days
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Major adverse events within 183 and 365 days
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within 183 and 365 days
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Stent Graft Migration
Time Frame: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
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Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging).
Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature.
Migration is observed when the stent graft completely covers a renal artery or movement is > 10 mm either distally or proximally.
Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is > 10 mm or coverage of the internal iliac artery.
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At 6- and 12-month follow-up visits (as compared to 1-month imaging)
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Aneurysm Expansion >5 mm
Time Frame: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
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Aneurysm expansion >5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
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at 6- and 12-month follow-up visits (as compared to 1-month imaging)
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All Endoleaks Based on Imaging Findings
Time Frame: at 1-, 6-, and 12-month follow-up visits
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All endoleaks based on imaging findings at 1-month, 6-month and 12-month.
An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.
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at 1-, 6-, and 12-month follow-up visits
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Stent Graft Occlusions Based on Imaging Findings
Time Frame: Through 1-, 6- and 12 months
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Stent graft occlusions based on imaging findings through 1-, 6- and 12 months.
Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.
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Through 1-, 6- and 12 months
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Device Deficiencies Based on Imaging Findings
Time Frame: Through 6- and 12 months
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Device deficiencies based on imaging findings through 6- and 12 months.
A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref.
ISO 14155:2011 3.15).
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Through 6- and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gilbert Upchurch, MD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10173341DOC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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