Complex Abdominal Aortic AneurysmNCT05339061
Physician Modified Endograft For Complex Aortic Aneurysm Repair
A study testing Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). in people with Complex Abdominal Aortic Aneurysm and Juxtarenal Aortic Aneurysm, run by University of California, Davis at 1 site in United States.
Trial summary
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Abdominal Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
- What is being tested?
- Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Dec 2029
- 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
---Inclusion criteria---
- Patient is > 18 years of age
- Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
- Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:
- Aortic aneurysm with diameter ≥ 5.5cm
- Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months
- Symptomatic aortic aneurysm
- Cannot be treated with a currently available non-modified approved device
- 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
- 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
- Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit
- Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
- Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
- The resultant repair should preserve patency in at least one hypogastric artery.
- Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm
- Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.
---Exclusion Criteria---
-General Exclusion Criteria-
- Patient has a mycotic aneurysm
- Patient has a ruptured aneurysm requiring urgent or emergent repair
- Patient has a systemic or local infection that may increase the risk of graft infection
- Patient has a body habitus that would inhibit X-ray visualization of the aorta.
- Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
- Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.
- Patient is currently participating in another investigational device or drug clinical trial.
-Medical Exclusion Criteria-
- Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
- Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
- Patient has uncorrectable coagulopathy
- Patient has 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 history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
- Patient has active malignancy with life expectancy of less than 2 years
- Patient has a limited life expectancy of less than 2 years.
- Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
-Anatomic Exclusion Criteria-
- Significant occlusive disease, tortuosity or calcification that would prevent endovascular access
- Proximal seal site with a circumferential thrombus/atheroma
- Inability to maintain at least one patent hypogastric artery
- Shaggy aorta
- Patient is not amenable to a temporary or permanent open surgical or endovascular conduit
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, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92037
Andrew Barleben, MD, MPH
Kathleen Groh
About this study
Official title: A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.
The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
Read the detailed description
The devices that will be used are Cook Medical © devices designed and approved for thoracic aortic and perivisceral aortic disease. These devices are all constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel or nitinol Cook-Z stents with braided polyester and monofilament polypropylene suture. The grafts are available in a straight or tapered configuration, both of which are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. These include Zenith TX2 Dissection Endovascular Grafts, The Zenith Alpha Thoracic Endovascular Graft and the Zenith Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft. These are all modular components that can be modified in a similar fashion. These can be used in conjunction with extension pieces for the Fenestrated AAA endograft system to extend into the iliac arteries.
The goal of this IDE is to repair complex aortic aneurysms involving the visceral vessels (renal arteries, superior mesenteric artery and/or celiac artery) while maintaining a minimally invasive approach. This requires a patient specific approach to each graft in order to land in normal artery above and below the disease.
The majority of the aneurysms treated will fall into the thoraco-abdominal aneurysm classification but there will be perivisceral aneurysms that involve one or more of the visceral vessels as well. These will involve fenestrations if preservation of flow is required in a landing zone or branches if preservation of flow is in the middle of the repair. All of these types of aneurysms do not have FDA approved devices to treat them. The investigators propose an approach to these aneurysms of at least 2 cm of seal proximal and distal to the aneurysmal disease. As this requires branches or fenestrations to preserve flow to the vital visceral vessels. Achieving at least 2 cm of seal within the normal aorta or iliac arteries.
Using these tenants, the approach to a repair and device choice is as follows. The investigators will evaluate the CT scan of the patient with an aneurysm that is off IFU for any other device who is high risk for a traditional open repair. The investigators will then identify the proximal and distal landing zones. If they involve any of the visceral vessels to do a peri-visceral nature, then these will likely be planned to be fenestrations. If they are not in the seal zone but in the middle of the aneurysm they will be planned as branches. Device size selection is based on the landing zone diameter and based on the device IFU.
A staged approach may be used to minimize risks that may be associated with a single extensive repair or improve technical success. This may include but not limited to performing a TEVAR landing above the diseased aorta at least 2 cm into normal thoracic aorta or open aortic graft down to the level of the celiac artery, treatment of a dissection with either a dissection stent or septotomy, or preoperative stenting or embolization of stenotic vessels or accessory vessels that will be covered and excluded during PMEG implantation to prevent endoleak. The potential benefit of a staged approach is one of ischemic conditioning of the spinal cord or staged microembolization to the lumbar arteries in order to minimize ischemic events and space them out over two procedures allowing alternative flow to the spinal cord to improve. There is also a benefit of staging the amount of contrast and fluoroscopy required to perform all of these procedures minimizing the impact of potential radiation exposure to patient and operator and the risk of contrast induced nephropathy. The staged procedure will be 2-4 weeks prior to PMEG implantation.
Once the plan is made and the devices are selected, the main modified device is created on a back table while the patient is being prepared by anesthesia using a plan that is measured from a CT scan with 1 mm cuts or finer in order to have precise and accurate measurements of the following criteria for each vessel:
- Diameter
- Length to first major branch (that cannot be covered)
- Arc length / clock location in comparison to reference vessel (SMA)
- Longitudinal distance from reference vessel (SMA)
- Angiographic view of the orifice of the vessel for optimal chance of cannulation
- Size of the aortic flow lumen at the origin of the target visceral vessel
- Degree of angulation at the vessel origin
- Predominant trajectory of the vessel (lateral vs cranial vs caudal) Once this is done then the investigators deploy the appropriately sized endograft for modification on a back table. This graft is sized per IFU to the patient's aorta at the location of the landing zones. If the patient has challenging access (small external iliac artery diameters) then the device of choice for modification is more likely to be the Cook Alpha device as this has a lower profile for delivery ensuring technical success of this portion of the procedure minimizing access complications such as iliac dissection and rupture. Also if there are primarily or only fenestrations in the plan for repair, then the investigators will also likely consider or commit to an alpha device as this device has more space between stent struts and there is more difficulty resheathing it with branches due to the smaller sheath size. Otherwise the Cook ZDEG device will be modified as this also does not have a precurved nature to it allowing for more precise delivery and has less difficulty with the resheathing process. If the proximal landing zone is in the visceral segment of the aorta, then the investigators will use the Cook Fenestrated Zenith device as it has a built-in constraining wire and is built for a transfemoral approach for a juxtarenal AAA or pararenal AAA.
Modification Process
- Deploy the graft on the sterile, surgical table
- Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary to avoid placing fenestrations over stents
- Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size
- If the fenestration is going to remain as such, then an EV3 Gooseneck snare is used to fashion the marker on the fenestration with Gore 5-0 stitch
- If the fenestration is going to be made into a branch, then an appropriately sized Gore, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a EV3 Gooseneck snare with the Gore 5-0 stitch.
- Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the EV3 Gooseneck snare sewn to the anterior portion of the graft in a "J" fashion with a Gore 5-0 stitch.
- The Graft is then sequentially constrained with care taken to ensure that the markers and branch orientation remain true.
Graft Implantation Process
- Graft orientation markers and fenestrations are identified under fluoroscopy in an extracorporeal manner with rotation in order to ensure markers are in location both front to back and side to side. This is completed both prior to resheathing and after. This is again confirmed when inserted to the appropriate level in the body.
- Using fusion imaging, the distal portions of the branches are put to 1-2 cm above the orifices of the arteries or fenestrations nearly at but slightly above the origins of the arteries.
- Once the graft has been delivered to the appropriate location, the graft is unsheathed one aortic stent at a time until the first branch has been deployed.
- Then from above, the vessels are sequentially cannulated with a wire and catheter with a catheter angiogram confirming the correct vessel.
- The bridging balloon expandable Gore VBX stents are then delivered over wire maximizing overlap with the target vessel and the branch while flaring proximally 2-4mm into the main body of the endograft.
- Once devices have been deployed, flow is ensured to be uninhibited by stenosis or dissection with a selective angiogram and then the endo grafting is extended distally into a previously placed endograft, normal aorta or surgically replaced aorta.
- Once completed another completion angiogram is performed to ensure flow through all the branch vessels, and no major correctable endoleaks.
- Conditions
- Complex Abdominal Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Being tested
- Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).Device
Modification
- Deploy the graft on the sterile, surgical table
- Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary
- Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size
- If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch
- If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch
- Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch
| Study group | Role | What they receive |
|---|---|---|
| Physician-Modified Endograft | Experimental | This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V). Receives: Device: Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Safety Endpoint (Freedom from major adverse events [MAE])
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Measured: At 30 days or during hospitalization if this exceeds 30 days.
Primary effectiveness endpoint
Treatment success is defined as a composite of technical success and freedom from the following:
- Aneurysm enlargement [i.e., >5mm as compared to any previous 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: The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
Secondary outcomes (3)
Technical success
Technical success and the individual components of technical success:
- Successful delivery
- Deployment at the intended implantation site
- Patency of all endovascular graft and stent components
- Absence of device deformations requiring unplanned placement of an additional device
- Absence of inadvertent occlusion of aorta or aortic branch vessels
- Successful withdrawal of delivery systems
Measured: Procedural
The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days
- All-cause mortality
- Myocardial infarction
- Respiratory failure requiring prolonged (>24 hours from anticipated) mechanical ventilation or reintubation
- Renal function decline resulting in >50% reduction in baseline eGFR or new-onset dialysis
- Bowel ischemia requiring surgical resection or not resolving with medical therapy
- Major stroke
- Paraplegia
Measured: At 30 days or during hospitalization if this exceeds 30 days.
Follow-up outcomes
The following at each follow-up interval:
- Treatment success and the individual components of treatment success including freedom from the following:
- Aneurysm sac changes (i.e enlargement, shrinkage, no change)
- Aneurysm-related mortality
- Aneurysm rupture
- Conversion to open repair
- Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events).
- Renal failure
- All-cause mortality
- Endoleaks
- Device integrity failure (e.g., fracture)
- Patency-related events (i.e., device stenosis or occlusion and embolic events)
- Other device-related events
Measured: The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Mar 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Complex Abdominal 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
- Model description
- This study is a prospective, single-center, non-randomized, single-arm study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339061
- Sponsor's protocol ID
- 803596
- Status last verified
- May 2026
- First submitted
- 14 Apr 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
O'Donnell TFX, Patel VI, Deery SE, Li C, Swerdlow NJ, Liang P, Beck AW, Schermerhorn ML. The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative. J Vasc Surg. 2019 Aug;70(2):369-380. doi: 10.1016/j.jvs.2018.11.021. Epub 2019 Feb 2.
PubMed 30718110Farber MA, Vallabhaneni R, Marston WA. "Off-the-shelf" devices for complex aortic aneurysm repair. J Vasc Surg. 2014 Sep;60(3):579-84. doi: 10.1016/j.jvs.2014.03.258. Epub 2014 May 3.
PubMed 24797555Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012 Sep;56(3):601-7. doi: 10.1016/j.jvs.2012.02.011. Epub 2012 May 2.
PubMed 22554425Sweet MP, Starnes BW, Tatum B. Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. J Vasc Surg. 2015 Nov;62(5):1160-7. doi: 10.1016/j.jvs.2015.05.036. Epub 2015 Jul 17.
PubMed 26194816Starnes BW, Heneghan RE, Tatum B. Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. J Vasc Surg. 2017 Feb;65(2):294-302. doi: 10.1016/j.jvs.2016.07.123. Epub 2016 Sep 26.
PubMed 27687323Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.
PubMed 30583902Han SM, Tenorio ER, Mirza AK, Zhang L, Weiss S, Oderich GS. Low-profile Zenith Alpha Thoracic Stent Graft Modification Using Preloaded Wires for Urgent Repair of Thoracoabdominal and Pararenal Abdominal Aortic Aneurysms. Ann Vasc Surg. 2020 Aug;67:14-25. doi: 10.1016/j.avsg.2020.02.022. Epub 2020 Mar 20.
PubMed 32205248Ronchey S, Serrao E, Kasemi H, Pecoraro F, Fazzini S, Alberti V, Mangialardi N. Endovascular treatment options for complex abdominal aortic aneurysms. J Vasc Interv Radiol. 2015 Jun;26(6):842-54. doi: 10.1016/j.jvir.2015.02.021. Epub 2015 Apr 14.
PubMed 25887934Scali ST, Neal D, Sollanek V, Martin T, Sablik J, Huber TS, Beck AW. Outcomes of surgeon-modified fenestrated-branched endograft repair for acute aortic pathology. J Vasc Surg. 2015 Nov;62(5):1148-59.e2. doi: 10.1016/j.jvs.2015.06.133. Epub 2015 Aug 5.
PubMed 26254453Senemaud JN, Ben Abdallah I, de Boissieu P, Touma J, Kobeiter H, Desgranges P, Becquemin JP, Cochennec F. Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. J Vasc Surg. 2020 Jun;71(6):1834-1842.e1. doi: 10.1016/j.jvs.2019.07.102. Epub 2019 Nov 7.
PubMed 31708298Singh A, Mafeld S, Williams R, McCaslin J. Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. Vasc Endovascular Surg. 2018 Nov;52(8):607-612. doi: 10.1177/1538574418789023. Epub 2018 Jul 22.
PubMed 30033825Tsilimparis N, Heidemann F, Rohlffs F, Diener H, Wipper S, Debus ES, Kolbel T. Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture. J Endovasc Ther. 2017 Dec;24(6):825-832. doi: 10.1177/1526602817729673. Epub 2017 Sep 6.
PubMed 28874089
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT05339061
- Acronym / sponsor ID
- 803596
- Conditions
- Complex Abdominal Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Apr 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 physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.
The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
Detailed description
The devices that will be used are Cook Medical © devices designed and approved for thoracic aortic and perivisceral aortic disease. These devices are all constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel or nitinol Cook-Z stents with braided polyester and monofilament polypropylene suture. The grafts are available in a straight or tapered configuration, both of which are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. These include Zenith TX2 Dissection Endovascular Grafts, The Zenith Alpha Thoracic Endovascular Graft and the Zenith Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft. These are all modular components that can be modified in a similar fashion. These can be used in conjunction with extension pieces for the Fenestrated AAA endograft system to extend into the iliac arteries.
The goal of this IDE is to repair complex aortic aneurysms involving the visceral vessels (renal arteries, superior mesenteric artery and/or celiac artery) while maintaining a minimally invasive approach. This requires a patient specific approach to each graft in order to land in normal artery above and below the disease.
The majority of the aneurysms treated will fall into the thoraco-abdominal aneurysm classification but there will be perivisceral aneurysms that involve one or more of the visceral vessels as well. These will involve fenestrations if preservation of flow is required in a landing zone or branches if preservation of flow is in the middle of the repair. All of these types of aneurysms do not have FDA approved devices to treat them. The investigators propose an approach to these aneurysms of at least 2 cm of seal proximal and distal to the aneurysmal disease. As this requires branches or fenestrations to preserve flow to the vital visceral vessels. Achieving at least 2 cm of seal within the normal aorta or iliac arteries.
Using these tenants, the approach to a repair and device choice is as follows. The investigators will evaluate the CT scan of the patient with an aneurysm that is off IFU for any other device who is high risk for a traditional open repair. The investigators will then identify the proximal and distal landing zones. If they involve any of the visceral vessels to do a peri-visceral nature, then these will likely be planned to be fenestrations. If they are not in the seal zone but in the middle of the aneurysm they will be planned as branches. Device size selection is based on the landing zone diameter and based on the device IFU.
A staged approach may be used to minimize risks that may be associated with a single extensive repair or improve technical success. This may include but not limited to performing a TEVAR landing above the diseased aorta at least 2 cm into normal thoracic aorta or open aortic graft down to the level of the celiac artery, treatment of a dissection with either a dissection stent or septotomy, or preoperative stenting or embolization of stenotic vessels or accessory vessels that will be covered and excluded during PMEG implantation to prevent endoleak. The potential benefit of a staged approach is one of ischemic conditioning of the spinal cord or staged microembolization to the lumbar arteries in order to minimize ischemic events and space them out over two procedures allowing alternative flow to the spinal cord to improve. There is also a benefit of staging the amount of contrast and fluoroscopy required to perform all of these procedures minimizing the impact of potential radiation exposure to patient and operator and the risk of contrast induced nephropathy. The staged procedure will be 2-4 weeks prior to PMEG implantation.
Once the plan is made and the devices are selected, the main modified device is created on a back table while the patient is being prepared by anesthesia using a plan that is measured from a CT scan with 1 mm cuts or finer in order to have precise and accurate measurements of the following criteria for each vessel:
- Diameter
- Length to first major branch (that cannot be covered)
- Arc length / clock location in comparison to reference vessel (SMA)
- Longitudinal distance from reference vessel (SMA)
- Angiographic view of the orifice of the vessel for optimal chance of cannulation
- Size of the aortic flow lumen at the origin of the target visceral vessel
- Degree of angulation at the vessel origin
- Predominant trajectory of the vessel (lateral vs cranial vs caudal) Once this is done then the investigators deploy the appropriately sized endograft for modification on a back table. This graft is sized per IFU to the patient's aorta at the location of the landing zones. If the patient has challenging access (small external iliac artery diameters) then the device of choice for modification is more likely to be the Cook Alpha device as this has a lower profile for delivery ensuring technical success of this portion of the procedure minimizing access complications such as iliac dissection and rupture. Also if there are primarily or only fenestrations in the plan for repair, then the investigators will also likely consider or commit to an alpha device as this device has more space between stent struts and there is more difficulty resheathing it with branches due to the smaller sheath size. Otherwise the Cook ZDEG device will be modified as this also does not have a precurved nature to it allowing for more precise delivery and has less difficulty with the resheathing process. If the proximal landing zone is in the visceral segment of the aorta, then the investigators will use the Cook Fenestrated Zenith device as it has a built-in constraining wire and is built for a transfemoral approach for a juxtarenal AAA or pararenal AAA.
Modification Process
- Deploy the graft on the sterile, surgical table
- Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary to avoid placing fenestrations over stents
- Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size
- If the fenestration is going to remain as such, then an EV3 Gooseneck snare is used to fashion the marker on the fenestration with Gore 5-0 stitch
- If the fenestration is going to be made into a branch, then an appropriately sized Gore, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a EV3 Gooseneck snare with the Gore 5-0 stitch.
- Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the EV3 Gooseneck snare sewn to the anterior portion of the graft in a "J" fashion with a Gore 5-0 stitch.
- The Graft is then sequentially constrained with care taken to ensure that the markers and branch orientation remain true.
Graft Implantation Process
- Graft orientation markers and fenestrations are identified under fluoroscopy in an extracorporeal manner with rotation in order to ensure markers are in location both front to back and side to side. This is completed both prior to resheathing and after. This is again confirmed when inserted to the appropriate level in the body.
- Using fusion imaging, the distal portions of the branches are put to 1-2 cm above the orifices of the arteries or fenestrations nearly at but slightly above the origins of the arteries.
- Once the graft has been delivered to the appropriate location, the graft is unsheathed one aortic stent at a time until the first branch has been deployed.
- Then from above, the vessels are sequentially cannulated with a wire and catheter with a catheter angiogram confirming the correct vessel.
- The bridging balloon expandable Gore VBX stents are then delivered over wire maximizing overlap with the target vessel and the branch while flaring proximally 2-4mm into the main body of the endograft.
- Once devices have been deployed, flow is ensured to be uninhibited by stenosis or dissection with a selective angiogram and then the endo grafting is extended distally into a previously placed endograft, normal aorta or surgically replaced aorta.
- Once completed another completion angiogram is performed to ensure flow through all the branch vessels, and no major correctable endoleaks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, single-center, non-randomized, single-arm study.
| Arm | Type | Receives |
|---|---|---|
| Physician-Modified Endograft | Experimental | Device: Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).Modification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch | Device | Physician-Modified Endograft |
Primary outcome
The Primary Safety Endpoint (Freedom from major adverse events [MAE])
Time frame: At 30 days or during hospitalization if this exceeds 30 days.
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Primary effectiveness endpoint
Time frame: The primary effectiveness endpoint is the 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 any previous 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)
3 secondary outcomes
Technical success
Time frame: Procedural
The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days
Time frame: At 30 days or during hospitalization if this exceeds 30 days.
Follow-up outcomes
Time frame: The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five 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 May 2026.
- Background: PubMed 30718110O'Donnell TFX, Patel VI, Deery SE, Li C, Swerdlow NJ, Liang P, Beck AW, Schermerhorn ML. The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative. J Vasc Surg. 2019 Aug;70(2):369-380. doi: 10.1016/j.jvs.2018.11.021. Epub 2019 Feb 2.
- Background: PubMed 24797555Farber MA, Vallabhaneni R, Marston WA. "Off-the-shelf" devices for complex aortic aneurysm repair. J Vasc Surg. 2014 Sep;60(3):579-84. doi: 10.1016/j.jvs.2014.03.258. Epub 2014 May 3.
- Background: PubMed 22554425Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012 Sep;56(3):601-7. doi: 10.1016/j.jvs.2012.02.011. Epub 2012 May 2.
- Background: PubMed 26194816Sweet MP, Starnes BW, Tatum B. Endovascular treatment of thoracoabdominal aortic aneurysm using physician-modified endografts. J Vasc Surg. 2015 Nov;62(5):1160-7. doi: 10.1016/j.jvs.2015.05.036. Epub 2015 Jul 17.
- Background: PubMed 27687323Starnes BW, Heneghan RE, Tatum B. Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms. J Vasc Surg. 2017 Feb;65(2):294-302. doi: 10.1016/j.jvs.2016.07.123. Epub 2016 Sep 26.
- Background: PubMed 30583902Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.
- Background: PubMed 32205248Han SM, Tenorio ER, Mirza AK, Zhang L, Weiss S, Oderich GS. Low-profile Zenith Alpha Thoracic Stent Graft Modification Using Preloaded Wires for Urgent Repair of Thoracoabdominal and Pararenal Abdominal Aortic Aneurysms. Ann Vasc Surg. 2020 Aug;67:14-25. doi: 10.1016/j.avsg.2020.02.022. Epub 2020 Mar 20.
- Background: PubMed 25887934Ronchey S, Serrao E, Kasemi H, Pecoraro F, Fazzini S, Alberti V, Mangialardi N. Endovascular treatment options for complex abdominal aortic aneurysms. J Vasc Interv Radiol. 2015 Jun;26(6):842-54. doi: 10.1016/j.jvir.2015.02.021. Epub 2015 Apr 14.
- Background: PubMed 26254453Scali ST, Neal D, Sollanek V, Martin T, Sablik J, Huber TS, Beck AW. Outcomes of surgeon-modified fenestrated-branched endograft repair for acute aortic pathology. J Vasc Surg. 2015 Nov;62(5):1148-59.e2. doi: 10.1016/j.jvs.2015.06.133. Epub 2015 Aug 5.
- Background: PubMed 31708298Senemaud JN, Ben Abdallah I, de Boissieu P, Touma J, Kobeiter H, Desgranges P, Becquemin JP, Cochennec F. Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms. J Vasc Surg. 2020 Jun;71(6):1834-1842.e1. doi: 10.1016/j.jvs.2019.07.102. Epub 2019 Nov 7.
- Background: PubMed 30033825Singh A, Mafeld S, Williams R, McCaslin J. Physician-Modified Fenestrated Endografts for Managing the Ruptured or Symptomatic Aortic Aneurysm: Technique Overview and Clinical Outcomes. Vasc Endovascular Surg. 2018 Nov;52(8):607-612. doi: 10.1177/1538574418789023. Epub 2018 Jul 22.
- Background: PubMed 28874089Tsilimparis N, Heidemann F, Rohlffs F, Diener H, Wipper S, Debus ES, Kolbel T. Outcome of Surgeon-Modified Fenestrated/Branched Stent-Grafts for Symptomatic Complex Aortic Pathologies or Contained Rupture. J Endovasc Ther. 2017 Dec;24(6):825-832. doi: 10.1177/1526602817729673. Epub 2017 Sep 6.
- 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 Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). in people with Complex Abdominal Aortic Aneurysm and Juxtarenal Aortic Aneurysm, run by University of California, Davis 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?
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: looking for participants now, as of the sponsor's last update on 6 May 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?
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 Sina Zarrintan, MD (8582463003, szarrintan@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Safety Endpoint (Freedom from major adverse events [MAE]) (time frame: At 30 days or during hospitalization if this exceeds 30 days.). The study lists 2 primary outcomes in all. 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 NCT05339061, which also lists 12 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 May 2026.