Endurant Evo International 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: NCT02461524

Lead Sponsor: Medtronic Cardiovascular

Brief Summary: The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.

Detailed Description: The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 69

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 CT 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 (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 bilaterally 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 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 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
Abdominal Aortic Aneurysm Endovascular repair	Endurant Evo AAA Stent Graft System	Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.
Abdominal Aortic Aneurysm Endovascular repair	Endovascular aneurysm repair (EVAR)	Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.	30 days	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
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.	Index procedure	Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), 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

Secondary Outcome Measures

Name	Time	Method
Number of Subject With Device Deficiencies Based on Imaging Findings	Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month	Total number of subject with Any Device Deficiency through the follow up time points.
Number of Subjects With All-Cause Mortality (ACM) at Each Follow up	Within 30, 183, and 365 days, then annually until 5-Year post-implantation	All-cause-mortality within 30, 183, and 365 days and annually until 5 years.
Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point	within 30, 183, and 365 days, then annually until 5-Year post-implantation	Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Conversion to Ppen Surgery	Within 30, 183, and 365 days, then annually until 5-Year post-implantation	Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation
The Number of Subjects With Major Adverse Events (MAE)	Within 183, and 365 days, then annually until 5-Year post-implantation	Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point	Within 30, 183, and 365 days, then annually until 5-Year post-implantation	Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation
The Number of Subjects With Aneurysm Rupture	Within 30, 183, and 365 days, then annually until 5-Year post-implantation	Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation
the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)	Through 12-month, 24-month, 36-month, 48-month and 60-month	Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case.
Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)	12-month, 24-month, 36-month, 48-month and 60-month	Aneurysm expansion \> 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point	within 30, 183, and 365 days, then annually until 5-Year post-implantation	Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation.
Number of Subjects With Serious Adverse Events (SAE)	within 30, 183, and 365 days, then annually until 5-Year post-implantation	Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation
Number of Subjects With Stent Graft Occlusion Based on Imaging Findings	Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month	Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Number of Subject With Endoleaks Based on Imaging Findings	1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month	Table will show a total number of subjects with endoleak at each follow up time point

Trial Locations

Locations (9): Odense Universitetshospital
🇩🇰
Odense, Denmark
Krankenhaus Hietzing
🇦🇹
Vienna, Austria
Rijnstate - Locatie Arnhem
🇳🇱
Arnhem, Netherlands
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Catharina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
Wilhelminenspital
🇦🇹
Vienna, Austria
UZ Leuven - Campus Gasthuisberg
🇧🇪
Leuven, Belgium
Erasmus University Medical Center
🇳🇱
Rotterdam, Netherlands
Skånes Universitetssjukhus Malmö
🇸🇪
Malmo, Sweden