Medtronic Endurant II or Endurant IIs Stent Graft System for Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prisma Health, Greenville, SC
Disease+6 More
Medtronic Endurant II or Endurant IIs Stent Graft System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects will be randomized and imaging will be collected at all follow-up time points to assess the primary endpoint.

Eligible Conditions

  • Disease
  • Aortic Aneurysm, Abdominal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 12 months and annually to 5 years

12 months
Sac Regression
Year 5
Aneurysm sac change by diameter as a continuous variable
Aneurysm sac change by volume incidence rate
Year 5
All cause mortality incidence rate
Secondary intervention incidence rate
Type II endoleak incidence rate
Year 5
Type I endoleak incidence rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Gore Excluder / Excluder Conformable
1 of 2
Medtronic Endurant II/IIs
1 of 2
Experimental Treatment

550 Total Participants · 2 Treatment Groups

Primary Treatment: Medtronic Endurant II or Endurant IIs Stent Graft System · No Placebo Group · N/A

Gore Excluder / Excluder Conformable
Device
Experimental Group · 1 Intervention: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis · Intervention Types: Device
Medtronic Endurant II/IIs
Device
Experimental Group · 1 Intervention: Medtronic Endurant II or Endurant IIs Stent Graft System · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months and annually to 5 years
Closest Location: Prisma Health · Greenville, SC
Photo of Greenville 1Photo of Greenville 2Photo of Greenville 3
2021First Recorded Clinical Trial
1 TrialsResearching Disease
18 CompletedClinical Trials

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
73 Previous Clinical Trials
35,674 Total Patients Enrolled
Marc Schermerhorn, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center, United States
3 Previous Clinical Trials
636 Total Patients Enrolled
Hence Verhagen, MDPrincipal InvestigatorErasmus University Medical Center, Netherlands

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an aneurysm size of ≥ 5 cm (if woman) ≥ 5.5 cm (if man).
The subject's anatomy is appropriate for both Gore Excluder/Excluder Conformable AAA Endoprosthesis and Endurant II/IIs Stent Graft System.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.