Thoracoabdominal AneurysmAssetsNCT05531084
Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms
A study testing Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex) in people with Thoracoabdominal Aneurysm and Juxtarenal Aortic Aneurysm, run by Jesse Manunga, MD at 1 site in United States.
Trial summary
The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aneurysm
- What is being tested?
- Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The subject has one or more of the following:
- 1. An aneurysm with a maximum diameter of > 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth > 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 8. High risk for open surgical repair based on any of the factors below:
- 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. Physiological high risk For this IDE, physiological risk will be assessed using two systems. First, this study will use the Society for Vascular Surgery (SVS)/American Association for Vascular Surgery (AAVS) medical comorbidity grading system recommended for use by the SVS to describe the severity of medical comorbidities in patients with complex aortic aneurysm disease. However, as the current SVS/AAVS grading system has yet to be validated in prospective studies or in a large cohort of patients treated for aortic disease, the American Association of Anesthesiologists grading system will also be utilized due to its widely adopted use and simplicity although it relies on subjective parameters and lacks specific metrics that affect outcomes.
- American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
- SVS/AAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
Show all 18Show fewer
- Medical Inclusion Criteria
- American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
- SVS/AAVS grading system: low risk (0.12-1% mortality risk), medium risk (1.7-4.9% mortality risk), and high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
- Anatomical Inclusion Criteria
- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit
- Extent of aorta to be treated: infrarenal aortic aneurysms with < 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone
- Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
- Minimum neck length of 20 mm
- Diameter in the range of 20 mm - 38 mm
- Angle less than 60 degrees relative to the axis of the aneurysm
- Angle less than 60 degrees relative to the axis of the suprarenal aorta
- Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm
Who cannot join
- Age: < 18 years old
- Does not meet the above inclusion criteria
- Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
- Unwilling or unable to comply with the follow-up schedule
- Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.
Show all 35Show fewer
- Subject is pregnant or breastfeeding
- Any other circumstance or condition which, at the discretion of the sponsor-investigator, makes the patient unsuitable for inclusion Medical Exclusion Criteria
- Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.
- 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
- Subject 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
- Baseline creatinine greater than 2.0 mg/dL
- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) with the exception of patients who have had prior open surgical aortic replacement where a surgical graft would serve as a "landing zone" for the investigational stent-graft Anatomical Exclusion Criteria
- Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
- Proximal neck length ≤20 mm
- Proximal neck, measured outer wall to outer wall on a sectional image (CT)
- For use of Zenith Fenestrated: diameter >32 mm or <18 mm
- For use of Zenith Alpha Thoracic: diameter >38 mm or <18 mm (for proximal and distal neck diameter)
- Zenith TX2 Dissection Endovascular graft: diameter 38 mm or <18 mm
- Zenith Flex AAA endovascular graft: diameter >32 mm or < 18 mm
- Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
- Proximal neck diameter changes 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
- Bilateral renal artery stenosis >80%
- Superior mesenteric artery stenosis >80%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
JoAnne Goldman, 612-863-3833, joanne.goldman@allina.com
About this study
Official title: Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms
The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).
Read the detailed description
The study is a prospective, non-randomized evaluation of endovascular repair of patients with failed previous infrarenal repairs (failed EVAR) and complex thoracoabdominal/juxtarenal/pararenal/paravisceral aortic aneurysm repair, including those with penetrating ulcers and aneurysms resulting from aortic dissections, who (1) have anatomy that is 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.
Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components. Whenever possible, the Zenith fenestrated universal bifurcated device will be used for patients requiring repair down to the iliac arteries. The Gore Excluder Endoprosthesis or the Gore Iliac Branch Endoprosthesis (IBE) will be used whenever the Zenith universal bifurcated device is not available. Safety and effectiveness will be assessed acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)), at 6 months, at 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
- Conditions
- Thoracoabdominal Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aneurysm, Aortic Aneurysm, Failed Previous Infrarenal Repairs (Failed EVAR)
- Being tested
- Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)
- Keywords
- surgeon-modified fenestrated stent grafts
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)Device
Also called Cook Zenith Alpha Thoracic Endovascular Graft (P140016), Cook Zenith Fenestrated AAA Endovascular Graft (P020018 S044), Cook Zenith TX2 Dissection Endovascular Graft (P180001), Cook Zenith Flex AAA Bifurcated Main Body (P020018 S055)
Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoabdominal aortic aneurysm extent I-III | Experimental | Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery): Receives: Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex) |
| Failed EVAR | Experimental | Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V: Receives: Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Primary outcome criteria:
- Mortality related to primary aortic disease and intervention
- All-cause mortality post intervention
Measured: 5 years
Secondary outcomes (5)
Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.
Secondary outcome criteria (as evidenced on follow up imaging and laboratory tests):
- Evidence of aortic disease progression (aneurysm growth >/=5 mm)
Measured: 5 years
Endoleak
presence of any endoleak requiring intervention
Measured: 5 years
Target vessels instability resulting in adverse events to the patient
- mesenteric ischemia
- renal failure
Measured: 5 years
procedure related complication
- stroke
- Myocardial infarction
- Paraplegia
Measured: 5 years
Issues associated with device migration and failure
- Device failure (migration >/=10 mm)
Measured: years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal 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
- Model description
- All participants will receive the same treatment modality (surgeon-modified fenestrated stent grafts).
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesse Manunga, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation
- Responsible party
- Sponsor-investigator, Jesse Manunga, MD, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531084
- Sponsor's protocol ID
- 1861968
- Acronym
- Assets
- Status last verified
- Oct 2022
- First submitted
- 8 Aug 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Manunga J, Hanif H, Cravero E, Behmanesh S, Stephenson E, Clark RM, Skeik N, Khasawneh M, Harris KM, Rana MA. Long-term outcomes of open versus endovascular complex aortic aneurysm repairs at centers without access to custom made devices in the fenestrated/branched stent graft era. J Vasc Surg. 2026 Jan;83(1):1-10. doi: 10.1016/j.jvs.2025.08.045. Epub 2025 Sep 10.
PubMed 40939900Manunga J, Cravero E, Goldman J, Stanberry LI, Stephenson E, Harris KM, Skeik N. Examining the impact of median arcuate ligament-induced celiac artery compression on target vessel patency, long-term survival and device integrity in fenestrated and branched endovascular repairs. J Vasc Surg. 2024 Oct;80(4):996-1005.e1. doi: 10.1016/j.jvs.2024.04.070. Epub 2024 May 7.
PubMed 38723909Manunga J, Stanberry LI, Skeik N, Hanif H, Rana MA. Use of physician-modified inverted limb in conjunction with Zenith fenestrated stent graft to rescue failed previous endovascular and open repair. J Vasc Surg. 2024 May;79(5):1101-1109. doi: 10.1016/j.jvs.2023.12.013. Epub 2023 Dec 14.
PubMed 38103807
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT05531084
- Acronym / sponsor ID
- Assets / 1861968
- Conditions
- Thoracoabdominal Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aneurysm, Aortic Aneurysm, Failed Previous Infrarenal Repairs (Failed EVAR)
- Keywords
- surgeon-modified fenestrated stent grafts
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Jesse Manunga, MDUniversity, hospital or other
- Collaborators
- Minneapolis Heart Institute Foundation
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 7 Sep 2022 (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 the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).
Detailed description
The study is a prospective, non-randomized evaluation of endovascular repair of patients with failed previous infrarenal repairs (failed EVAR) and complex thoracoabdominal/juxtarenal/pararenal/paravisceral aortic aneurysm repair, including those with penetrating ulcers and aneurysms resulting from aortic dissections, who (1) have anatomy that is 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.
Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components. Whenever possible, the Zenith fenestrated universal bifurcated device will be used for patients requiring repair down to the iliac arteries. The Gore Excluder Endoprosthesis or the Gore Iliac Branch Endoprosthesis (IBE) will be used whenever the Zenith universal bifurcated device is not available. Safety and effectiveness will be assessed acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)), at 6 months, at 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive the same treatment modality (surgeon-modified fenestrated stent grafts).
| Arm | Type | Receives |
|---|---|---|
| Thoracoabdominal aortic aneurysm extent I-III | Experimental | Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery): |
| Failed EVAR | Experimental | Device: Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V: |
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
- The subject has one or more of the following:
- 1. An aneurysm with a maximum diameter of > 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth > 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 8. High risk for open surgical repair based on any of the factors below:
- American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
- SVS/AAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
Key exclusion criteria (35 listed)
- Age: < 18 years old
- Does not meet the above inclusion criteria
- Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
- Unwilling or unable to comply with the follow-up schedule
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 |
|---|---|---|
| Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)Also: Cook Zenith Alpha Thoracic Endovascular Graft (P140016), Cook Zenith Fenestrated AAA Endovascular Graft (P020018 S044), Cook Zenith TX2 Dissection Endovascular Graft (P180001), Cook Zenith Flex AAA Bifurcated Main Body (P020018 S055)Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components. | Device | Failed EVAR, Thoracoabdominal aortic aneurysm extent I-III |
Primary outcome
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Time frame: 5 years
Primary outcome criteria: * Mortality related to primary aortic disease and intervention * All-cause mortality post intervention
5 secondary outcomes
Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.
Time frame: 5 years
Endoleak
Time frame: 5 years
Target vessels instability resulting in adverse events to the patient
Time frame: 5 years
procedure related complication
Time frame: 5 years
Issues associated with device migration and failure
Time frame: years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 40939900Manunga J, Hanif H, Cravero E, Behmanesh S, Stephenson E, Clark RM, Skeik N, Khasawneh M, Harris KM, Rana MA. Long-term outcomes of open versus endovascular complex aortic aneurysm repairs at centers without access to custom made devices in the fenestrated/branched stent graft era. J Vasc Surg. 2026 Jan;83(1):1-10. doi: 10.1016/j.jvs.2025.08.045. Epub 2025 Sep 10.
- Derived from this study: PubMed 38723909Manunga J, Cravero E, Goldman J, Stanberry LI, Stephenson E, Harris KM, Skeik N. Examining the impact of median arcuate ligament-induced celiac artery compression on target vessel patency, long-term survival and device integrity in fenestrated and branched endovascular repairs. J Vasc Surg. 2024 Oct;80(4):996-1005.e1. doi: 10.1016/j.jvs.2024.04.070. Epub 2024 May 7.
- Derived from this study: PubMed 38103807Manunga J, Stanberry LI, Skeik N, Hanif H, Rana MA. Use of physician-modified inverted limb in conjunction with Zenith fenestrated stent graft to rescue failed previous endovascular and open repair. J Vasc Surg. 2024 May;79(5):1101-1109. doi: 10.1016/j.jvs.2023.12.013. Epub 2023 Dec 14.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex) in people with Thoracoabdominal Aneurysm and Juxtarenal Aortic Aneurysm, run by Jesse Manunga, MD 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 35 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: opening soon, as of the sponsor's last update on 6 Oct 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesse Manunga, MD, FSVS, FACS (612-863-6800, jesse.manunga@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of aortic aneurysm related mortality and all cause mortality post intervention (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531084, which also lists 3 linked publications.
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 6 Oct 2022.