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Endovascular Graft

Custom-Made Endograft for Aortic Aneurysm (CARPE-CMD Trial)

N/A

Recruiting

Led By Andres Schanzer, MD

Research Sponsored by Andres Schanzer

Eligibility Criteria Checklist

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

Must have

Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device

No systemic or local infection that may increase the risk of endovascular graft infection

Must not have

Proximal neck length ≤25 mm

Iliac artery distal fixation site <10 mm in length

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of custom-made devices and physician-modified devices to treat complex abdominal, thoracoabdominal, and aortic arch aneurysms in people who are at high risk for open surgical repair.

Who is the study for?

Adults with complex aortic aneurysms unsuitable for standard endovascular repair, at high risk for open surgery, or with specific connective tissue disorders like Marfan, Ehlers-Danlos, or Loeys-Dietz syndromes. Participants must not be pregnant/breastfeeding and able to follow up for five years.

What is being tested?

The trial is testing custom-made stent grafts and modified FDA-approved devices on patients who can't use standard grafts due to their unique anatomy or those who cannot wait for traditional device manufacturing because of the severity of their condition.

What are the potential side effects?

Potential side effects may include complications related to the implantation procedure such as infection, allergic reactions to materials in the stent graft (stainless steel, polyester), blood vessel damage during insertion, and issues from long-term wear.

Eligibility Criteria

Inclusion Criteria

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

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I need immediate treatment and cannot wait for standard devices.

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I do not have any infections that could risk a graft infection.

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I am considered high risk for traditional surgery due to my condition or body's structure.

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I am 18 years old or older.

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My aortic aneurysm is growing quickly or needs repair due to symptoms.

Exclusion Criteria

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

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The length of my neck's upper part is 25 mm or less.

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The end of my iliac artery is less than 10 mm long.

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The artery segment for stenting is less than 15 mm long and not forked.

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My doctor expects I have less than 2 years to live due to my cancer.

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My blood vessels are too narrow or twisted for certain medical procedures.

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The artery needing a stent is either less than 3 mm or more than 10 mm wide.

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I have a blood clotting disorder that cannot be corrected.

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My blood vessel has a clot or plaque at the site needing a seal.

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I have unstable chest pain.

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My aneurysm's neck is angled over 60 degrees.

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I cannot keep at least one of my pelvic arteries open.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success

Secondary study objectives

Incidence of Major Adverse Events