Juxtarenal Aortic AneurysmNCT04526938
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
A study testing Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft in people with Juxtarenal Aortic Aneurysm and Suprarenal Aortic Aneurysm, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxtarenal Aortic Aneurysm, Suprarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to Sep 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Life expectancy > 2 year(s)
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
- A patient may be entered into the study if the patient has at least one of the following:
- Juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter
- Aneurysm with a history of growth ≥ 0.5 cm per year
Show all 18Show fewer
- Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
- Symptomatic juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm
- Thoracoabdominal aortic aneurysms secondary to aortic dissection meeting above criteria
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
- Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a:
- Minimum neck length of 20mm
- Diameter in the range of 21-38mm
- Angle less than 60° relative to the axis of the aneurysm
- Angle less than 60° relative to the axis of the suprarenal aorta
- Minimum branch vessel diameter greater than 5 mm
- Iliac artery distal fixation site greater than 10mm in length and diameter in the range of 8-21mm.
Who cannot join
- Under the age of 18 years
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
- Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
- Unwilling or unable to comply with the follow-up schedule
Show all 33Show fewer
- Inability or refusal to give informed consent by patient or legal representative
- Patient is pregnant or breastfeeding
- Life expectancy < 2-years despite successful aneurysm exclusion
- Free rupture with hemodynamic instability
- Ongoing infection
- Diagnosis of, or suspected connective tissue disease
- Known sensitivities or allergies to the materials of construction of the devices
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- Uncorrectable coagulopathy
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection
- Leaking or free rupture of aneurysm associated with hemodynamic instability.
- Baseline creatinine greater than 3.0 mg/dL
- Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
- Anatomical exclusion criteria:
- Inadequate femoral or iliac access compatible with the required delivery systems, not amenable to open surgical or endovascular conduit placement
- Absence of a non-aneurysmal aortic segment for proximal seal zone with:
- A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
- Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
- Visceral vessel anatomy not compatible with physician-modified Zenith® Alpha Endovascular Graft due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy:
- Common iliac artery fixation site diameter measured outer wall to outer wall on a sectional image (CT) <8.0 mm with inability to perform open surgical conduit
- Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
- Iliac artery distal fixation site <10 mm in length
- Inability to preserve at least one hypogastric artery
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
Read the detailed description
This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant.
- Being tested
- Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
- Keywords
- Complex Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Modified Cook Zenith Alpha Thoracic Endovascular GraftDevice
Cook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular repair | Experimental | Endovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft. Receives: Device: Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Events (MAE) at 30 days
Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke
Measured: 30 days
Proportion of study subjects with treatment success at 1 year
Treatment success is defined as a composite of technical success and freedom from the following:
- Aneurysm enlargement [i.e., >5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements]
- Aneurysm rupture
- Aneurysm-related mortality
- Conversion to open repair
- Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Measured: 1 year
Technical success
Technical success is defined as:
- Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location,
- Patency of all endovascular graft and branch stent components
- Absence of device deformations requiring unplanned placement of an additional device
- Absence of inadvertent covering of aortic branch vessels
- Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)
Measured: 1 year
Secondary outcomes (1)
Quality of Life measures
Questionnaire using SF - 36™ Health Survey
Measured: 30 days, 6 months; 1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start20 Sep 2021
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juxtarenal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javairiah Fatima, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526938
- Sponsor's protocol ID
- FEVAR
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2020
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes, Radiation Dosage, and Quality of Life in Patients Treated With Fenestrated Stent Grafts for Complex Thoracoabdominal and Abdominal Aortic Aneurysms, Thoracoabdominal Aortic Aneurysms Secondary to Aortic Dissections
- ClinicalTrials.gov ID
- NCT04526938
- Acronym / sponsor ID
- FEVAR
- Keywords
- Complex Aortic Aneurysm, Complex Abdominal Aortic Aneurysm, Aneurysm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI left institution
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
Detailed description
This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiography (CTA) of chest, abdomen and pelvis, abdominal duplex ultrasound, creatinine measurement, quality of life questionnaire at specific, protocol-defined intervals for a period of five years following the physician-modified Cook Zenith® Alpha Endovascular Graft implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular repair | Experimental | Device: Physician-Modified Cook Zenith Alpha Thoracic Endovascular GraftEndovascular repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms including those secondary to aortic dissection using a physician-modified endovascular graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years old
- Life expectancy > 2 year(s)
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
- A patient may be entered into the study if the patient has at least one of the following:
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
Key exclusion criteria (33 listed)
- Under the age of 18 years
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
- Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-Modified Cook Zenith Alpha Thoracic Endovascular GraftCook Zenith® Alpha Thoracic Endovascular Graft will be modified to allow for the maintenance of blood flow into the visceral and renal branch vessels. | Device | Endovascular repair |
Primary outcome
Freedom from Major Adverse Events (MAE) at 30 days
Time frame: 30 days
Major Adverse Events include: Death, Bowel Ischemia, myocardial infarction, paraplegia/paraparesis, renal failure, respiratory failure, and stroke
Proportion of study subjects with treatment success at 1 year
Time frame: 1 year
Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement [i.e., >5mm) as compared to a preoperative CT measure using orthogonal (i.e, perpendicular to the centerline) measurements] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Technical success
Time frame: 1 year
Technical success is defined as: * Successful delivery (i.e., ability to deliver the implant to the intended implantation site, without the need for unanticipated corrective intervention related to delivery) and deployment of the device at the intended location, * Patency of all endovascular graft and branch stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent covering of aortic branch vessels * Successful withdrawal (i.e., successful withdrawal of the delivery system, without need for unanticipated corrective intervention related to withdrawal)
1 secondary outcome
Quality of Life measures
Time frame: 30 days, 6 months; 1, 2, 3, 4 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javairiah Fatima, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft in people with Juxtarenal Aortic Aneurysm and Suprarenal Aortic Aneurysm, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Major Adverse Events (MAE) at 30 days (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.