An interventional study of Fenestrated CMD and Type I - III TAAA in Aortic Aneurysm, Abdominal and Thoracic Aneurysm, sponsored by Carlos Timaran. Enrolling by invitation at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Carlos Timaran · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop
This study is a prospective, single center, non-randomized, triple-cohort study. For the Fenestrated-CMD cohort a total of 350 patients will be enrolled. For the type I-III thoracoabdominal cohort, a total of 250 patients will be enrolled. For the Arch cohort, 25 patients will be enrolled. CMDs will be used primarily. Off-the-shelf devices will be used in urgent cases and when the waiting period for design and manufacturing of a CMD may not be considered acceptable. Staged endovascular repair will be used for type I, II and III TAAAs and for concurrent arch and TAAAs, unless the condition of the patient requires a single stage endovascular repair. A separate subgroup analysis of patients undergoing procedures with off-the-shelf devices will be performed.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 750 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →This is the only study on the registry with Carlos Timaran as lead sponsor.
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General Inclusion Criteria
A patient is deemed suitable for inclusion in the study if the patient has at least one of the following:
General Exclusion Criteria
A patient must be excluded from the clinical investigation if any of the following are true:
Medical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
Anatomical Exclusion Criteria
Patient must be excluded from the study if any of the following are true:
Absence of a landing aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
Unsuitable distal iliac arterial fixation site and anatomy:
For patients in the type I-III TAAA cohort, the intended use criteria are the same for both the fenestrated/branched CMD vs the off-the-shelf device. The CMD will preferably be used, unless an urgent repair is indicated or the waiting period for design or manufacturing of the CMD is considered unacceptable.
Additional anatomical inclusion criteria for aortic arch devices
Proximal aortic fixation zone:
Distal aortic fixation zone:
Supra-aortic trunk (brachiocephalic) vessels
i. Innominate artery
1. Native vessel or surgical graft
2. Diameter: 8-22mm
3. Length of sealing zone ≥10mm
4. Acceptable tortuosity
ii. Left (or right) common carotid artery
iii. Left (or right) subclavian artery
4. In the setting of an aortic dissection, the following criteria must exist:
A true lumen size large enough to deploy the device and still gain access into the target branches
5. In the setting of more distal disease, the repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device.
6. Iliac anatomy must allow for the delivery of the arch branch device, which is loaded within a 20F-24F sheath. Conduits to the iliac vessels or aorta may be used if deemed necessary.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.
Device: Fenestrated CMD
Patients enrolled in this arm will be implanted with the custom-made/ off-the-shelf branched devices. The device is aimed to treat type I-III TAAAs.
Device: Type I - III TAAA
Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.
Device: Arch cohort
The CMD that will be used in this IDE is structurally the same as the commercially available Zenith Fenestrated AAA Endovascular Graft. In general, the Zenith® Fenestrated AAA Endovascular Graft is a modular system constructed of full- thickness woven polyester fabric sewn to self-expanding stainless steel z-stents with braided polyester and monofilament polypropylene sutures. In this study, fenestrated grafts with up to 4 fenestrations may be used. Device implantation will be performed using standardized endovascular techniques used in the treatment of abdominal aortic aneurysms.
Also known as: Cook Zenith® Fenestrated CMD
Device implantation will be performed using standardized endovascular techniques used in the treatment of abdominal aortic aneurysms. Devices will be implanted in patients with type I-III thoracic abdominal aneurysms. The branches in this study will be constructed as internal/external cuffs, axially oriented and either caudally or cranially directed, as necessary. The branch position will be determined by the anatomic location of the target vessels using a consistent craniocaudal and circumferential cuff position.
Also known as: CMD-off-the-shelf branched devices-
Arch branched devices may be designed using one of two configurations: (1) Zone 0 device with two inner antegrade branches for the innominate artery and the left common carotid artery with or without a retrograde left subclavian artery branch and (2) Zone 1-2 device with a single retrograde subclavian artery branch with double or triple wide scallop for the left common carotid artery. These devices are designed for a of proximal landing/fixation zone of at least 20 mm of healthy aortic segment or a previous graft.
Also known as: Zenith Arch Branch Device
Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.
Primary safety will be defined as the proportion of subjects who experience a major adverse event (MAE) at 30-days or during hospitalization if this exceeds 30 days.
Time frame: 30 days
Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.
For primary effectiveness endpoint, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12-months.
Time frame: 12-months
Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success)
Technical success is defined as successful access of the aneurysm site and deployment of endovascular graft in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography.
Time frame: 30 days
Number of Major adverse events
Major adverse events are defined as the occurrence of any of the following: death, aneurysm rupture, or conversion to open surgical repair; Q wave myocardial infarction (MI); cardiac ischemia requiring intervention; renal failure requiring dialysis; bowel obstruction or bowel ischemia requiring intensification of medical therapy or surgical therapy; aorto-enteric fistula; stroke; paralysis.
Time frame: 5 years
Number of participants with adverse events from the use of bare metal stents as a measure of safety
When bare metal balloon expandable or self-expandable stents are required to be used distally to covered stents, target vessel events (kink, stenosis or occlusion) will be analyzed separately at 30 days, 6 months and annually up to five years.
Time frame: 5 years
Rate of complications not considered as major (Secondary safety endpoints)
Other Major adverse events such as paraplegia and paraparesis, stroke and specific mortality.
Time frame: 30 days
Rate of successful procedures and treatment in terms of device integrity (Secondary effectiveness endpoints)
Treatment success and procedure success. Endograft integrity will be evaluated within this outcome measurement.
Time frame: 5 years
Number of participants with adverse events from radiation exposure as a measure of tolerability.
Skin changes secondary to radiation exposure will be evaluated within this outcome measurement.
Time frame: 5 years
Rate of major adverse events in patients treated with low profile devices (Safety for low profile devices)
Safety will be defined as the proportion of subjects who experience a major adverse event for patients treated with low profile devices.
Time frame: 5 years
Rate of procedures with successful access of aneurysm site and deployment of low profile devices with patent stenting of target vessels (Effectiveness for low profile devices)
Effectiveness is defined as technical success (successful access of the aneurysm site and deployment of endovascular graft in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography)of low profile devices use.
Time frame: 5 years
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