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Endoprosthesis

Endoprosthesis for Abdominal Aortic Aneurysm

N/A
Waitlist Available
Led By Robert Rhee, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or infertile female
AAA meeting any of the following criteria: Maximum diameter ≥50 mm, Rapid growth (>5 mm in a 6 month period), Non-ruptured AAA presenting with clinical symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis for treating abdominal aortic aneurysms.

Who is the study for?
This trial is for adults over 21 with abdominal aortic aneurysms (AAA) that are large, growing quickly, or causing symptoms. Participants must have a life expectancy over 2 years and suitable anatomy for the device implant. Exclusions include those with certain medical conditions like connective tissue disease, severe kidney issues, or allergies to device materials.Check my eligibility
What is being tested?
The study tests the GORE® EXCLUDER® Conformable AAA Endoprosthesis's safety and effectiveness in treating infrarenal abdominal aortic aneurysms. The endoprosthesis performance will be evaluated against specific goals to determine its suitability as a treatment option.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to the implant procedure such as infection, bleeding, blood vessel damage, or adverse reactions to the device material if one has sensitivities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a woman unable to have children.
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My abdominal aorta is enlarged, growing quickly, or causing symptoms without bursting.
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My body is suitable for a specific AAA stent based on artery sizes and angles.
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I am 21 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness as measured by a composite of Adverse Events
Safety as measured by a composite of Adverse Events
Secondary outcome measures
AAA enlargement ≥5 mm with or without intervention
AAA rupture
Aneurysm-related mortality
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Short Neck SubstudyExperimental Treatment1 Intervention
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
Group II: High Neck Angulation SubstudyExperimental Treatment1 Intervention
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Find a Location

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,154 Total Patients Enrolled
Robert Rhee, MDPrincipal InvestigatorMaimonides Medical Center (US)
1 Previous Clinical Trials
379 Total Patients Enrolled

Media Library

GORE® EXCLUDER® Conformable AAA Endoprosthesis (Endoprosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT02489539 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Short Neck Substudy, High Neck Angulation Substudy
Abdominal Aortic Aneurysm Clinical Trial 2023: GORE® EXCLUDER® Conformable AAA Endoprosthesis Highlights & Side Effects. Trial Name: NCT02489539 — N/A
GORE® EXCLUDER® Conformable AAA Endoprosthesis (Endoprosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02489539 — N/A

Frequently Asked Questions

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

What are the primary objectives of this experimental research?

"Over the course of one year, researchers will observe a composite of safety-related Adverse Events to determine this clinical trial's primary outcome. Secondary objectives involve assessing Migration (10 mm or more) as an indicator for efficacy, identifying Type III endoleaks in connection with effectiveness, and evaluating Stent fracture through core lab analysis for further evidence of efficacy."

Answered by AI

How many participants are there in this experiment?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is recruiting participants, with the original posting and subsequent editing occurring on December 19th 2017 and April 25th 2022 respectively. 190 individuals across 45 sites need to be enrolled in total."

Answered by AI

Are there many locations in Canada currently conducting this experiment?

"This trial is available at 45 different sites including Ochsner Clinic Foundation in New Orleans, River City Clinical Research in Jacksonville and Essentia Institute of Rural Health located in Duluth."

Answered by AI

Is there a call for volunteers at this moment to participate in the research?

"According to clinicaltrials.gov, this study is actively recruiting participants as of April 25th 2022 - a trial that was originally posted in December 19th 2017."

Answered by AI
~61 spots leftby Aug 2027