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Endovascular Graft

Endovascular Graft Repair for Aortic Aneurysm

N/A

Recruiting

Led By Javairiah Fatima, MD

Research Sponsored by Medstar Health Research Institute

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years old

Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit

Must not have

Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Diagnosis of, or suspected connective tissue disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device to treat complex aortic aneurysms and thoracoabdominal aortic aneurysms in high-risk patients. The trial will assess the safety and preliminary effectiveness of the device, as well as renal function, radiation exposure, and quality of life.

Who is the study for?

This trial is for adults with large aortic aneurysms who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, compatible anatomy for the device, and no severe allergies to device materials. Pregnant or breastfeeding individuals, those with certain connective tissue diseases or infections, and those unable to undergo imaging tests due to body size are excluded.

What is being tested?

The study is testing a modified Cook Alpha Thoracic Endovascular Graft in patients with complex aortic aneurysms. It aims to evaluate the safety and initial effectiveness of this custom-fit graft designed by physicians specifically for each patient's unique anatomy.

What are the potential side effects?

Potential side effects may include complications related to the endovascular procedure such as blood vessel damage, infection risks from implanting the device, kidney function impairment due to contrast media used during imaging tests, and radiation exposure from X-rays.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My blood vessels in the hip or thigh area are suitable for medical procedures.

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My aortic aneurysm is due to a tear in the aorta's wall.

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My aneurysm has grown at least 0.5 cm in a year.

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My aortic aneurysm is larger than 5.5 cm or twice the normal size.

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I have a painful aneurysm near or above my kidneys or in my chest and abdomen area.

Exclusion Criteria

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

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I have or might have a connective tissue disorder like Marfan or Ehler's Danlos Syndrome.

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I have or may have a connective tissue disease.

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I am under 18 years old.

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My aneurysm has burst causing unstable blood pressure.

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I have a blood clotting disorder that cannot be corrected.

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I am currently fighting an infection.

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I have worsening chest pain, including new pain at rest or at night.

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I am allergic to blood thinners or contrast dyes that can't be managed with medication.

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My body size may prevent clear x-ray images or is too large for the equipment.

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I have internal bleeding causing unstable blood pressure.

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My iliac artery is not suitable for certain types of vascular surgery due to its size or condition.

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I have an infection that could risk a graft infection.

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My veins are not suitable for certain medical procedures without open surgery.

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

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

Primary study objectives

Freedom from Major Adverse Events (MAE) at 30 days

Proportion of study subjects with treatment success at 1 year

Technical success

Secondary study objectives

Quality of Life measures

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endovascular repairExperimental Treatment1 Intervention

Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft.

0 / 19Eligibility criteria met