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New treatment option for Complex Aortic Aneurysms
Official title Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
ClinicalTrials.gov ID: NCT02050113
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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...
- 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 \ 10 mm at the vessel ostium
- Inability to maintain at least one patent hypogastric artery
The study team makes the final eligibility decision.
Where it's taking place
- Worcester, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Worcester, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.