Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients

NCT07224230 | Recruiting DMC FDA Device

• 2 other identifiers: H-57126G240006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure of their previous devices. The use of physician-modified endografts aims to shift the seal zone proximally above the celiac artery in order to treat their complex or thoracoabdominal aneurysms in a minimally invasive fashion. These patients are considered too high risk to survive open surgical repair and do not meet anatomic criteria for the Gore Thoracoabdominal Multi Branch Endoprosthesis, which is currently the only FDA approved device in the US to treat these aneurysms. The primary objective is to evaluate safety and effective of physician modified endografts in the treatment of thorax-abdominal aneurysms and complex aortic aneurysms. For primary safety endpoints, mortality and major adverse events (MAE) will be analyzed at 30 days or in hospitalization (if this exceeds 30 days). Primary endpoints include the following: 1. Mortality related to primary aortic disease 2. Aneurysm rupture 3. All cause mortality For primary effectiveness endpoints, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12 months. Treatment success is defined by a composite endpoint, which includes all of the following criteria: Technical success (defined as successful delivery and deployment of the physician modified endograft with perseveration of those branch vessels intended to be preserved, freedom from type I or type III endoleak, freedom from stent graft migration, freedom from aneurysm enlargement \>5mm, freedom from aneurysm rupture or conversion to open repair. Secondary objectives of the study include assessment of individual safety and effectiveness endpoints as follows: technical success, procedure success, mortality, major adverse events - specifically renal, cardia, pulmonary, gastrointestinal, and neurologic. Each endpoint will be analyzed separately. Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years. Secondary endpoints to be analyzed are the following: 1. Evidence of Aortic Disease Progression: Monitoring for aneurysm growth \> 5 mm from baseline measurements. 2. Device Failure: Evaluation of device performance, including migration \> 10 mm, device degradation, and loss of device integrity. 3. Endoleaks: Monitoring for the occurrence and classification of endoleaks as outlined in the clinical outcome definitions. 4. Secondary Interventions: Description and analysis of secondary interventions aimed at treating branch vessel stenosis, occlusion, or embolization. 5. Significant Lifestyle-Limiting or Disabling Complications: Assessment and reporting of complications resulting in significant impairment of daily life, such as stroke-induced paralysis (paraplegia). 6. Cardiac Dysfunction: Monitoring and analysis of cardiac events, including myocardial infarction, congestive heart failure, and cardiac ischemia requiring intervention. 7. Renal Events: Evaluation of renal complications, including the need for dialysis, deterioration of renal function, and renal failure. 8. Mesenteric Events: Description and classification of mesenteric complications, such as ischemia and the need for surgical resection. 9. Respiratory Events: Monitoring for respiratory complications, including respiratory failure and prolonged intubation Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years

Conditions

Abdominal Aortic Aneurysms; Thoracoabdominal Aneurysms; Pararenal Aortic Aneurysm

Keywords

PMEG; abdominal aortic aneurysms; thoracoabdominal aneurysms; pararenal aortic aneurysms

Outcome Measures

Primary Outcomes (2)

• Mortality

  Primary endpoints include the following: Mortality related to primary aortic disease or all cause mortality during the 5 year follow up of the study

  5 years

• Aneurysm rupture

  Any imaging or clinical evidence of rupture of the aortic aneurysm being treated

  5 years

Secondary Outcomes (9)

• Evidence of Aortic Disease Progression

  5 years

• Device Failure

  5 years

• Endoleaks

  5 years

• Secondary Interventions

  5 years

• Significant Lifestyle-limiting or disabling complications

  5 years

Study Arms (1)

Thoracoabdominal and aortic aneurysm arm

EXPERIMENTAL

The Zenith Endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The physician will be creating fenestrations or branches' locations based on the the patient's anatomy. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Device: Physician Modified Endograft

Interventions

Physician Modified Endograft DEVICE

The Zenith Alpha and TX2 grafts are tubular grafts made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be opened under sterile conditions and modifications for fenestrations or branches will be created based on the patient's specific anatomy. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Thoracoabdominal and aortic aneurysm arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \> 18 years of age.
• Patients who are male or non-pregnant female (females of childbearing 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
• The subject has at least one of the following:
• An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females
• Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos.
• Symptomatic aneurysm
• Morphology such as saccular aneurysms
• Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
• Cannot be treated with a currently available non-modified approved device.
• Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit.
• Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm.
• Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm.
• The resultant repair should preserve patency in at least one hypogastric artery.
• Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm.

You may not qualify if:

• patient has a mycotic aneurysm
• patient has a systemic or local infection that may increase the risk of graft infection.
• 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.
• Patient is currently participating in another investigational device or drug clinical trial.
• Eligible for treatment with FDA-approved marketed device
• Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution.
• Unwilling to comply with the follow-up schedule.
• Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding.
• Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pretreatment
• Uncorrectable coagulopathy
• 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.
• History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less than 2 years.
• Patient has a limited life expectancy of less than 2 years.

Sponsors & Collaborators

• Steven Maximus: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (11)

• Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.

  PMID: 17980540 BACKGROUND

• Schanzer A, Greenberg RK, Hevelone N, Robinson WP, Eslami MH, Goldberg RJ, Messina L. Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair. Circulation. 2011 Jun 21;123(24):2848-55. doi: 10.1161/CIRCULATIONAHA.110.014902. Epub 2011 Apr 10.

  PMID: 21478500 BACKGROUND

• Oderich GS. Technique of adding a diameter-reducing wire to the modified TX2 fenestrated stent graft. Vascular. 2010 Nov-Dec;18(6):350-5. doi: 10.2310/6670.2010.00059.

  PMID: 20979923 BACKGROUND

• Starnes 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.

  PMID: 22554425 BACKGROUND

• Oderich GS, Fatima J, Gloviczki P. Stent graft modification with mini-cuff reinforced fenestrations for urgent repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2011 Nov;54(5):1522-6. doi: 10.1016/j.jvs.2011.06.023. Epub 2011 Sep 16.

  PMID: 21925826 BACKGROUND

• Tse LW, Steinmetz OK, Abraham CZ, Valenti DA, Mackenzie KS, Obrand DI, Chuter TA. Branched endovascular stent-graft for suprarenal aortic aneurysm: the future of aortic stent-grafting? Can J Surg. 2004 Aug;47(4):257-62.

  PMID: 15362327 BACKGROUND

• Starnes BW, Zettervall S, Larimore A, Singh N. Long-Term Results of Physician-Modified Endografts for the Treatment of Elective, Symptomatic, and Ruptured Juxtarenal Abdominal Aortic Aneurysms. Ann Surg. 2024 Oct 1;280(4):633-639. doi: 10.1097/SLA.0000000000006422. Epub 2024 Jun 26.

  PMID: 38920026 BACKGROUND

• Starnes BW, Tatum B. Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts. J Vasc Surg. 2013 Aug;58(2):311-7. doi: 10.1016/j.jvs.2013.01.029. Epub 2013 May 3.

  PMID: 23643560 BACKGROUND

• Oderich GS, Ricotta JJ 2nd. Modified fenestrated stent grafts: device design, modifications, implantation, and current applications. Perspect Vasc Surg Endovasc Ther. 2009 Sep;21(3):157-67. doi: 10.1177/1531003509351594. Epub 2009 Dec 3.

  PMID: 19965792 BACKGROUND

• Fulton JJ, Farber MA, Marston WA, Mendes R, Mauro MA, Keagy BA. Endovascular stent-graft repair of pararenal and type IV thoracoabdominal aortic aneurysms with adjunctive visceral reconstruction. J Vasc Surg. 2005 Feb;41(2):191-8. doi: 10.1016/j.jvs.2004.10.049.

  PMID: 15767997 BACKGROUND

• Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S171-8. doi: 10.1016/j.jtcvs.2010.07.061.

  PMID: 21092788 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Steven Maximus, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Martinez

CONTACT

713-798-6835; andrea.martinez@bcm.edu

Steven Maximus, MD

CONTACT

951-206-9835; steven.maximus@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)