Subjects who receive the Treovance stent-graft for Aneurysm

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Aneurysm+3 More
Subjects who receive the Treovance stent-graft - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new stent-graft for people with abdominal aortic aneurysms. They want to see if it's safe and effective.

Eligible Conditions
  • Aneurysm
  • Aortic Aneurysm, Abdominal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Primary Efficacy
30 days
Primary Safety
Month 12
Secondary Safety Endpoint
Month 6
Secondary Efficacy Endpoint -- Device-Related Complications
Month 6
Secondary Efficacy Endpoint-- Secondary interventions

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treovance
1 of 1
Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Subjects who receive the Treovance stent-graft · No Placebo Group · Phase 2

Treovance
Device
Experimental Group · 1 Intervention: Subjects who receive the Treovance stent-graft · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Bolton MedicalLead Sponsor
14 Previous Clinical Trials
2,276 Total Patients Enrolled
12 Trials studying Aneurysm
2,170 Patients Enrolled for Aneurysm
Matthew Eagleton, MDPrincipal InvestigatorCleveland Clinic Foundaton
1 Previous Clinical Trials
143 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 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.