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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

Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including: Adequate iliac / femoral access, Infrarenal aortic neck diameter 16-32 mm, Infrarenal aortic neck length ≥10 mm, Aortic neck angle ≤ 90˚, Distal iliac artery seal zone ≥10 mm, Iliac artery diameter 8-25 mm

Must not have

Known concomitant thoracic aortic aneurysm which requires surgical intervention

Systemic infection which may increase the risk of endovascular graft infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a thoracic aortic aneurysm that needs surgery.

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I have an infection that could risk a graft infection.

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I am scheduled for a major surgery within the next 30 days.

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I have a fungal or burst blood vessel bulge.

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My heart condition severely limits my physical activity.

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My blood vessel condition is not suitable for standard procedures.

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My leg arteries are very narrow or twisted.

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I have a condition like Marfan or Ehler-Danlos Syndrome.

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My kidney function is low, with creatinine over 2.5 mg/dL or I am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Subjects Free From Primary Safety Endpoint Event

Number of Subjects With Device Treatment Success

Secondary study objectives

Median Hospital Stay

Median Index Procedure Time

Median Procedural Blood Loss (mL)

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 12Eligibility criteria met