Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

NCT02050113 | Recruiting DMC FDA Device

• 1 other identifier: CARPE-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy 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. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Conditions

Complex Aortic Aneurysms; Thoracoabdominal Aneurysms; Pararenal Aneurysms; Juxtarenal Aneurysms; Marfan Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; Aortic Arch Aneurysm

Keywords

Complex Aortic Aneurysms; Thoracoabdominal Aneurysms; Pararenal Aortic Aneurysms; Juxtarenal Renal Aneurysms; Endovascular Branch Graft; Fenestrated Stent Graft; Abdominal Aortic Aneurysm; Endovascular; Aortic Dissection; Aortic Arch Aneurysms

Outcome Measures

Primary Outcomes (1)

• The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success

  Treatment success is a combination of technical success, and freedom at 12 months from the following: Type 1 and 3 Endoleaks, Stent migration of more than 10 mm, aortic aneurysm enlargement sac enlargement of more than 5 mm, aneurysm rupture and conversion to open repair.

  12 months post procedure

Secondary Outcomes (1)

• Incidence of Major Adverse Events

  Within 30 days of the initial procedure

Study Arms (1)

Endovascular repair

EXPERIMENTAL

Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.

Device: Custom Made Fenestrated or Branched Stent Graft

Interventions

Custom Made Fenestrated or Branched Stent Graft DEVICE

The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.

Also known as: t-Branch Device, Physician Modified Device, Arch Branch Device

Endovascular repair

Eligibility Criteria

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

You may qualify if:

• Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
• Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
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• Cannot be treated with a currently available non-modified approved device
• Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
• At least 18 years of age
• Not pregnant or breastfeeding
• Willing and able to comply with five years of follow-up
• Willing and able to provide informed consent prior to enrollment
• No systemic or local infection that may increase the risk of endovascular graft infection
• High risk for open surgical repair based on any of the factors below:
• a. 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. 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

You may not qualify if:

• Cultural objection to receipt of blood or blood products
• Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
• Anaphylactic reaction to contrast that cannot be adequately pre-medicated
• Uncorrectable coagulopathy
• 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 active malignancy with life expectancy of less than 2 years
• Patient has life expectancy less than two years
• Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
• Proximal neck length ≤25 mm
• Proximal neck, measured outer wall to outer wall on a sectional image (CT)
• For use of Zenith Flex: diameter \>32 mm or \<18 mm
• For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
• Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
• Proximal neck diameter change over the length of the proximal seal zone \>4 mm
• Proximal seal site with a circumferential thrombus/atheroma

Sponsors & Collaborators

• Andres Schanzer: lead

Study Sites (1)

UMass Memorial Health Care - University Campus

Worcester, Massachusetts, 01655, United States

RECRUITING

Related Publications (7)

• Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2025 Feb 18. doi: 10.1097/SLA.0000000000006676. Online ahead of print.

  PMID: 39963789 DERIVED

• Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11.

  PMID: 38989575 DERIVED

• Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.

  PMID: 37330702 DERIVED

• Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13.

  PMID: 37059239 DERIVED

• Finnesgard EJ, Simons JP, Jones DW, Judelson DR, Aiello FA, Boitano LT, Sorensen CM, Nguyen TT, Schanzer A. Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair. J Vasc Surg. 2023 Apr;77(4):975-981. doi: 10.1016/j.jvs.2022.11.041. Epub 2022 Nov 13.

  PMID: 36384183 DERIVED

• Alqaim M, Cosar E, Crawford AS, Robichaud DI, Walz JM, Schanzer A, Simons JP. Lumbar drain complications in patients undergoing fenestrated or branched endovascular aortic aneurysm repair: Development of an institutional protocol for lumbar drain management. J Vasc Surg. 2020 Nov;72(5):1576-1583. doi: 10.1016/j.jvs.2020.02.013. Epub 2020 Apr 2.

  PMID: 32249045 DERIVED

• Schanzer A, Baril D, Robinson WP 3rd, Simons JP, Aiello FA, Messina LM. Developing a complex endovascular fenestrated and branched aortic program. J Vasc Surg. 2015 Mar;61(3):826-31. doi: 10.1016/j.jvs.2014.08.121. Epub 2015 Jan 13.

  PMID: 25595400 DERIVED

MeSH Terms

Conditions

Marfan Syndrome; Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; Aneurysm, Aortic Arch; Aortic Aneurysm, Abdominal; Aortic Dissection

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Hemostatic Disorders; Vascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Skin Diseases, Genetic; Collagen Diseases; Skin Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Aortic Aneurysm; Aneurysm; Aortic Diseases; Aortic Aneurysm, Thoracic; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Andres Schanzer, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shauneen Valliere, MSN, NP

CONTACT

508-856-1767; shauneen.valliere@umassmed.edu

Andres Schanzer, MD

CONTACT

508-856-5599; andres.schanzer@umassmemorial.org

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: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: March 1, 2014
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)