NCT02050113 · Andres Schanzer
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
(CARPE-CMD)
What this study is about
The purpose of this study is to evaluate the safety and effectiveness 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 group of participants 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 <!-- -->
- 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
- 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
Where
- Worcester, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations