ClinicalTrials.gov record NCT02050113

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study evaluates custom-made stent grafts, Zenith t-Branch devices, and physician-modified FDA-approved grafts to treat complex aortic and aortoiliac aneurysms, including some thoracoabdominal and aortic arch aneurysms. It focuses on patients whose anatomy is not suitable for currently marketed devices, those unsafe to wait for manufacturing, or those at high risk for open surgery. An amendment added a cohort that may include people with connective tissue disorders such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndromes.

What it is studying. Whether custom-made, t-Branch, and physician-modified endovascular stent grafts can be used safely and successfully to repair complex aortic aneurysms and preserve blood flow to organs.

What the researchers hope to learn. The study's scientific goals are to evaluate the safety and effectiveness of these devices. Primary evaluation includes a composite 12-month "treatment success" outcome (technical success and freedom from Type 1/3 endoleaks, stent migration >10 mm, aneurysm sac enlargement >5 mm, rupture, or conversion to open repair). A key secondary goal is to measure the incidence of major adverse events within 30 days (including death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, or procedural blood loss >1 liter).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Custom Made Fenestrated or Branched Stent Graft

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • A patient may be suitable for inclusion in the study if the patient has at least one of the following:
  • Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
  • Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
  • General Inclusion Criteria
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  • Cannot be treated with a currently available non-modified approved device
  • Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
  • At least 18 years of age
  • Not pregnant or breastfeeding
  • Willing and able to comply with five years of follow-up
  • Willing and able to provide informed consent prior to enrollment
  • No systemic or local infection that may increase the risk of endovascular graft infection
  • High risk for open surgical repair based on any of the factors below:
  • a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age >70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD

Exclusion criteria

  • Exclusion Criteria Medical Exclusion Criteria
  • Cultural objection to receipt of blood or blood products
  • Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
  • Anaphylactic reaction to contrast that cannot be adequately pre-medicated
  • Uncorrectable coagulopathy
  • Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  • Patient has active malignancy with life expectancy of less than 2 years
  • Patient has life expectancy less than two years
  • Anatomical Exclusion Criteria
  • Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
  • Proximal neck length ≤25 mm
  • Proximal neck, measured outer wall to outer wall on a sectional image (CT)
  • For use of Zenith Flex: diameter >32 mm or <18 mm
  • For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck diameter)
  • Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
  • Proximal neck diameter change over the length of the proximal seal zone >4 mm
  • Proximal seal site with a circumferential thrombus/atheroma
  • Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) <7.0 mm at any point along access length (prior to deployment)
  • Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) >21 mm at distal fixation site
  • Iliac artery distal fixation site <10 mm in length
  • Non-bifurcated segment of any artery to be stented < 15 mm in length
  • Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium
  • Inability to maintain at least one patent hypogastric artery

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Endovascular repair of complex aortic aneurysms is limited by the need to maintain blood flow to the critical organs that receive blood from the aorta, such as the kidneys, liver and intestines. While there are some commercially available devices that may treat some of these patients these devices may not be suitable or available for a given patient. In this study we will use custom made devices manufactured by Cook, Inc, Zenith t-Branch devices and off-the-shelf, FDA approved devices which are altered by creating fenestrations (holes) in the stent graft that allow additional stents to be inserted into the blood vessels that supply blood to these critical organs. Determination of which type of endograft to use will be based on the patient's anatomy and the perceived urgency of the need for repair. This decision will be made by the study team and confirmed by a 3rd party reviewer who is not an investigator on the study team. After ensuring that a patient meets inclusion and exclusion criteria for participation in the CARPE-CMD study, the perceived urgency for repair will be evaluated given the 6-8 week required time for manufacture of a CMD device. If the patient's aneurysm is not symptomatic and if, at the discretion of the treating surgeon, the patient is deemed safe to wait 8 weeks until repair, the patient will be considered non-urgent. Non-urgent patients will undergo repair with a CMD device. If the patient's aneurysm is symptomatic and if, at the discretion of the treating surgeon, the patient is deemed unsafe to wait 8 weeks until repair, the patient will be considered urgent. Urgent patients will undergo repair with a t-branch device (if anatomy suitable) Urgent patients who do not have anatomy suitable to a t-branch device or patients who are not deemed safe to wait for the device to be obtained, will undergo repair with a physician modified device. The device is inserted into the body through two small punctures or incisions in the groin. Small stents will be inserted through the stent graft fenestrations into the major blood vessels affected by the aneurysm so that blood flow is maintained to these organs.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If eligible, the treating team will choose a device based on your anatomy and urgency; a third‑party reviewer will confirm the decision. The procedure is an endovascular repair performed through small punctures or incisions in the groin (and sometimes the upper arm), using a custom‑made device, a Zenith t‑Branch, or a physician‑modified FDA‑approved graft with fenestrations; small stents are placed through those fenestrations into branch arteries (kidney, liver, intestinal vessels, or carotid/subclavian for arch repairs) to maintain blood flow. You would have the initial procedure and then follow-up visits and imaging to check the graft, with outcomes assessed at 12 months and follow-up planned for five years.

How the study is structured. This is a single-group, non-masked interventional study where participants receive endovascular repair using a custom-made fenestrated or branched stent graft, a Zenith t-Branch device, or a physician-modified off-the-shelf graft. The choice of device is based on the patient's anatomy and urgency and is reviewed by the study team and an independent reviewer. The procedure is performed through small incisions in the groin (and sometimes the upper arm), and small branch stents are placed through fenestrations to maintain blood flow to organs.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Marfan syndrome

This trial is also listed on this site under Loeys-Dietz syndrome.

Clinical trials20 trials listed for Marfan syndromeEvery trial the registry lists for Marfan syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Marfan syndrome researchLatest monthly update: September 2026. Includes: After open aortic repair. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
March 2014
Primary completion
March 2030 (estimated)
Study completion
March 2030 (estimated)
Target enrollment
600 participants (estimated)
Last updated on registry
Oct 22, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Andres Schanzer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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