Endurant Evo International Clinical Trial

NCT02461524 | Terminated Results DMC

• 1 other identifier: 10173339DOC
• Study Type: interventional
• Target: 69
• Locations: 5 countries
• Sites: 9

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.

Conditions

Abdominal Aortic Aneurysm; AAA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

• 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

• 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

• 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

• Number of Subjects With Serious Adverse Events (SAE)

  within 30, 183, and 365 days, then annually until 5-Year post-implantation

Study Arms (1)

Abdominal Aortic Aneurysm Endovascular repair

OTHER

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)

Interventions

Endurant Evo AAA Stent Graft System DEVICE

Abdominal Aortic Aneurysm Endovascular repair

Endovascular aneurysm repair (EVAR) PROCEDURE

Abdominal Aortic Aneurysm Endovascular repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (9)

Krankenhaus Hietzing

Vienna, Austria

Location

Wilhelminenspital

Vienna, Austria

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Odense Universitetshospital

Odense, Denmark

Location

Rijnstate - Locatie Arnhem

Arnhem, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Skånes Universitetssjukhus Malmö

Malmo, Sweden

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Kristel Wittebols Sr. Clinical Research Director
• Organization: Medtronic

kristel.wittebols@medtronic.com

31 (0)43-3566566

Study Officials

• Hence Verhagen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2015
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); AU (2); DK (1); BE (2); SE (1)