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Endovascular Aneurysm Repair Device

Nellix System for Abdominal Aortic Aneurysm (EVAS2 Trial)

Q: Is registration currently open for this experiment?

<p>Clinicaltrials.gov states that the recruitment phase for this clinical trial has ended; it was initially posted on December 1st 2017 and had its last update on September 30th 2021. However, 241 other studies are actively looking for patients currently.</p>

Q: Is this experimental protocol being administered widely throughout Canada?

<p>A plethora of sites are recruiting for this medical trial, including Mass General in Boston, Wellmont CVA Hearth Institute in Kingsport and Inova Research Center in Falls Church. An additional 31 locations are also providing the necessary resources to complete the study's objectives.</p>

N/A

Waitlist Available

Led By Jeffrey Carpenter, MD

Research Sponsored by Endologix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.

Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

EVAS2 Trial Summary

This trial will prospectively study the Nellix System in subjects with abdominal aortic aneurysms. The trial will be single arm and multicenter, meaning multiple sites will enroll eligible subjects consecutively. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

Who is the study for?

This trial is for adults with abdominal aortic aneurysms that are large or growing quickly, who have suitable blood vessel anatomy for the Nellix System. Participants must understand and sign consent forms, agree to follow-up visits, and not be pregnant or have certain health conditions like severe kidney issues or recent heart attacks.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of the Nellix System in repairing abdominal aortic aneurysms. It's a single group study where all participants will receive this endovascular repair procedure at various medical centers.See study design

What are the potential side effects?

While specific side effects aren't listed here, endovascular procedures can generally cause reactions such as bleeding, infection risk at the incision site, potential damage to blood vessels, and sometimes may lead to further interventions if complications occur.

EVAS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My abdominal aortic aneurysm is larger than 5.0cm, or it has grown by more than 0.5cm in the last 6 months.

Select...

My iliac artery is the right size for the procedure.

Select...

One of my hypogastric arteries can be saved.

Select...

My aorta near the aneurysm is not enlarged, is 10-28mm wide, and angles ≤60°.

Select...

My blood vessels are wide enough for the needed medical equipment.

Select...

My common iliac artery is between 9 and 35mm wide.

EVAS2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Major Adverse Events (MAE)

Rate of Treatment Success

EVAS2 Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

EndologixLead Sponsor

22 Previous Clinical Trials

3,874 Total Patients Enrolled

Jeffrey Carpenter, MDPrincipal InvestigatorCooper Hospital

1 Previous Clinical Trials

333 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration currently open for this experiment?

"Clinicaltrials.gov states that the recruitment phase for this clinical trial has ended; it was initially posted on December 1st 2017 and had its last update on September 30th 2021. However, 241 other studies are actively looking for patients currently."

Answered by AI

Is this experimental protocol being administered widely throughout Canada?

"A plethora of sites are recruiting for this medical trial, including Mass General in Boston, Wellmont CVA Hearth Institute in Kingsport and Inova Research Center in Falls Church. An additional 31 locations are also providing the necessary resources to complete the study's objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

2017. "EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03298477.

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