Endurant Evo International Clinical Trial

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Endurant Evo International Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02461524
• Other study ID #: 10173339DOC
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 25, 2021

Study information

• Verified date: September 2023
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AAA
• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endurant Evo AAA Stent Graft System

Procedure:
• Endovascular aneurysm repair (EVAR)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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