Clinical trial NCT02461524: Endurant Evo International Clinical Trial
Official title: Endurant Evo International Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
AAA
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation.
timeFrame: 30 days
measure: Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure.
timeFrame: Index procedure
Secondary outcomes:
measure: Number of Subjects With All-Cause Mortality (ACM) at Each Follow up
timeFrame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point
timeFrame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point
timeFrame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point
timeFrame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: Number of Subjects With Serious Adverse Events (SAE)
timeFrame: within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: The Number of Subjects With Aneurysm Rupture
timeFrame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: The Number of Subjects With Conversion to Ppen Surgery
timeFrame: Within 30, 183, and 365 days, then annually until 5-Year post-implantation
measure: The Number of Subjects With Major Adverse Events (MAE)
timeFrame: Within 183, and 365 days, then annually until 5-Year post-implantation
measure: the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging)
timeFrame: Through 12-month, 24-month, 36-month, 48-month and 60-month
measure: Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging)
timeFrame: 12-month, 24-month, 36-month, 48-month and 60-month
measure: Number of Subject With Endoleaks Based on Imaging Findings
timeFrame: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
measure: Number of Subjects With Stent Graft Occlusion Based on Imaging Findings
timeFrame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
measure: Number of Subject With Device Deficiencies Based on Imaging Findings
timeFrame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Arnhem
country: Netherlands
facility: Rijnstate - Locatie Arnhem
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus Malmö
Study officials:
affiliation: Erasmus Medical Center
name: Hence Verhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: