Endurant Evo US Clinical Trial

Not Applicable

Terminated

Conditions: AAA
Abdominal Aortic Aneurysm

Interventions: Device: Endurant Evo AAA Stent Graft System
Procedure: Endovascular aneurysm repair (EVAR)

Registration Number: NCT02393716

Lead Sponsor: Medtronic Cardiovascular

Brief Summary: The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.

Detailed Description: The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 139

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular repair	Endovascular aneurysm repair (EVAR)	Endurant Evo AAA Stent Graft System
Endovascular repair	Endurant Evo AAA Stent Graft System	Endurant Evo AAA Stent Graft System

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.	30-days	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: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.	12-months	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: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco

Secondary Outcome Measures

Name	Time	Method
Aneurysm Rupture	within 183 and 365 days	Aneurysm rupture within 183 and 365 days
All Endoleaks Based on Imaging Findings	at 1-, 6-, and 12-month follow-up visits	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.
Secondary Procedures to Correct Type I and III Endoleaks	within 183, and 365 days	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.
Serious Adverse Events	within 30, 183, and 365 days	Serious adverse events within 30, 183 and 365 days.
All-cause Mortality	within 30, 183, and 365 days	All-cause mortality (ACM) within 30, 183, 365 days
Stent Graft Migration	At 6- and 12-month follow-up visits (as compared to 1-month imaging)	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.
Aneurysm-related Mortality (ARM)	within 30, 183, and 365 days	Aneurysm-related mortality (ARM) within 30, 183, and 365 days
Conversion to Open Surgery	within 183, and 365 days	Conversion to open surgery within 183, and 365 days
Aneurysm Expansion >5 mm	at 6- and 12-month follow-up visits (as compared to 1-month imaging)	Aneurysm expansion \>5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Device Deficiencies Based on Imaging Findings	Through 6- and 12 months	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).
Secondary Procedures	within 183, and 365 days	Secondary procedures within 183 and 365 days
Major Adverse Events	within 183 and 365 days	Major adverse events within 183 and 365 days
Stent Graft Occlusions Based on Imaging Findings	Through 1-, 6- and 12 months	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.

Trial Locations

Locations (14): Medstar Heart & Vascular Institute
🇺🇸
Washington, District of Columbia, United States
UPMC Pinnacle Harrisburg Campus
🇺🇸
Harrisburg, Pennsylvania, United States
Stanford Hospital & Clinics
🇺🇸
Stanford, California, United States
Long Island Jewish Northshore University Hospital
🇺🇸
New Hyde Park, New York, United States
Providence Sacred Heart Medical Center
🇺🇸
Spokane, Washington, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Kaiser Permanente Zion Medical Center
🇺🇸
San Diego, California, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Aurora St. Lukes Medial Center
🇺🇸
Milwaukee, Wisconsin, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Erlanger Medical Center
🇺🇸
Chattanooga, Tennessee, United States
University of Michigan Health Sysem
🇺🇸
Ann Arbor, Michigan, United States
Heart Hospital of Austin
🇺🇸
Austin, Texas, United States