Endurant Evo International Clinical Trial

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.

Study Overview

• Status: Terminated
• Conditions: Abdominal Aortic Aneurysm; AAA
• Intervention / Treatment: Device: Endurant Evo AAA Stent Graft System; Procedure: Endovascular aneurysm repair (EVAR)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Wilhelminenspital
  • Vienna, Austria
    • Krankenhaus Hietzing
• Belgium
  • Gent, Belgium
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium
    • UZ Leuven - Campus Gasthuisberg
• Denmark
  • Odense, Denmark
    • Odense Universitetshospital
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate - Locatie Arnhem
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus University Medical Center
• Sweden
  • Malmo, Sweden
    • Skånes Universitetssjukhus Malmö

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is ≥ 18 years old
2. Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board.
3. Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
4. 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

5. 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

6. 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:

1. Subject has a life expectancy ≤ 1 year
2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
3. Subject is pregnant

4. Subject has an aneurysm that is:

   • Suprarenal/ pararenal/ juxtarenal
   • Isolated ilio-femoral
   • Mycotic
   • Inflammatory
   • Pseudoaneurysm
   • Dissecting
   • Ruptured
   • Leaking but not ruptured
5. Subject requires emergent aneurysm treatment
6. Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at time of screening
7. Subject has been previously treated for an abdominal aortic aneurysm
8. Subject has a history of bleeding diathesis or coagulopathy
9. 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
10. 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
11. Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
12. Subject has a known allergy or intolerance to the device materials
13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
14. 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
15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
16. 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
17. Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
18. 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
19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
20. Subject has a creatinine level >2.00 mg/dl (or >176.8 µmol/L)
21. 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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Abdominal Aortic Aneurysm Endovascular repair; Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.	Device: Endurant Evo AAA Stent Graft System; Procedure: Endovascular aneurysm repair (EVAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint Assessed by the Number of Participants 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	30 days
Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the 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	Index procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Hence Verhagen, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): June 25, 2021

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimated): June 3, 2015

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 10173339DOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO