Alto Abdominal Stent Graft System for Abdominal Aortic Aneurysm

Phase-Based Progress Estimates
Oregon Health Sciences University, Portland, ORAbdominal Aortic AneurysmAlto Abdominal Stent Graft System - Device
All Sexes
What conditions do you have?

Study Summary

This trial will compare two types of devices used in a common surgery to fix an aortic aneurysm.

Eligible Conditions
  • Abdominal Aortic Aneurysm

Treatment Effectiveness

Study Objectives

2 Primary · 18 Secondary · Reporting Duration: Through 5 years

Month 12
Count of participants with aneurysm sac enlargement (>5mm)
Count of participants with device migration (>10mm)
Month 12
Tubal Occlusion
Number of Participants with Freedom From device-related interventions
Month 12
Number of Major Adverse Events (MAEs)
Month 12
Count of participants AAA-related Mortality
Count of participants All Cause Mortality
Count of participants with conversion to open surgery
Count of participants with type I and III endoleaks
Count of subjects lacking device integrity
Number of Secondary interventions
Number of Type II
Number of Type III
Number of Type IV
Number of Type Ia endoleaks
Number of Type Ib
Number of Unknown Enooleaks
count of aneurysm ruptures
Through 5 years
Neck Dilation in mm
Number of Participants with Freedom from Aneurysm-Related Complications (ARC)

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
Alto Abdominal Stent Graft System
1 of 2

Active Control

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Alto Abdominal Stent Graft System · No Placebo Group · N/A

Alto Abdominal Stent Graft System
Experimental Group · 1 Intervention: Alto Abdominal Stent Graft System · Intervention Types: Device
ActiveComparator Group · 1 Intervention: FDA Approved EVAR AAA Graft Systems · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 5 years

Who is running the clinical trial?

EndologixLead Sponsor
18 Previous Clinical Trials
2,810 Total Patients Enrolled
Sean Lyden, MDPrincipal InvestigatorThe Cleveland Clinic
6 Previous Clinical Trials
1,706 Total Patients Enrolled
Christopher Kwolek, MDPrincipal InvestigatorNewton-Wellesley Hospital
4 Previous Clinical Trials
1,503 Total Patients Enrolled
Hence Verhagen, MD, PhDPrincipal InvestigatorErasmus University Study Center
2 Previous Clinical Trials
519 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least two more years.

Frequently Asked Questions

Is the enrollment phase of this trial still ongoing?

"The evidence on suggests that this research project, which was initially advertised on September 20th 2021, is still recruiting participants. The most recent update to the study's information came through October 12th 2022." - Anonymous Online Contributor

Unverified Answer

How many subjects are being recruited for participation in this trial?

"To successfully complete the trial, 450 qualified patients need to partake in it. Those interested can attend either Houston Methodist Research Institute located in Texas or University of Arizona based out of Tucson." - Anonymous Online Contributor

Unverified Answer

Are there multiple sites in the U.S. conducting this research experiment?

"Presently, 22 medical centres are working to find suitable candidates for this trial. These include the Houston Methodist Research Institute in Houston, University of Arizona in Tucson, as well as Feinstein Institutes for Medical Research (Staten Island University Hospital/Northwell Health) located on Staten Island and many other sites throughout the country." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.