Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

NCT02266719 | Enrolling By Invitation DMC

• 1 other identifier: G140108
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop

Conditions

Aortic Aneurysm, Abdominal; Thoracic Aneurysm

Keywords

Aortic Aneurysm, Abdominal [C14.907.055.239.075]; Thoracic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.

  Primary safety will be defined as the proportion of subjects who experience a major adverse event (MAE) at 30-days or during hospitalization if this exceeds 30 days.

  30 days

• Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.

  For primary effectiveness endpoint, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12-months.

  12-months

Secondary Outcomes (3)

• Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success)

  30 days

• Number of Major adverse events

  5 years

• Number of participants with adverse events from the use of bare metal stents as a measure of safety

  5 years

Other Outcomes (5)

• Rate of complications not considered as major (Secondary safety endpoints)

  30 days

• Rate of successful procedures and treatment in terms of device integrity (Secondary effectiveness endpoints)

  5 years

• Number of participants with adverse events from radiation exposure as a measure of tolerability.

  5 years

Study Arms (3)

Fenestrated CMD cohort

EXPERIMENTAL

Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Device: Fenestrated CMD

Type I - III TAAA cohort

EXPERIMENTAL

Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.

Device: Type I - III TAAA

Arch cohort

EXPERIMENTAL

Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.

Device: Arch cohort

Interventions

Fenestrated CMD DEVICE

The CMD that will be used in this IDE is structurally the same as the commercially available Zenith Fenestrated AAA Endovascular Graft. In general, the Zenith® Fenestrated AAA Endovascular Graft is a modular system constructed of full- thickness woven polyster fabric sewn to self-expanding stainless steel z-stents with braided polyster and monofilament polypropylene sutures. In this study, fenestrated grafts with usually up to 4 fenestrations may be used. Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms.

Also known as: Cook Zenith® Fenestrated CMD

Fenestrated CMD cohort

Type I - III TAAA DEVICE

Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms. Devices will be implanted in patients with type I-III thoracic abdominal aneurysms. The branches in this study will be constructed as internal/external cuffs, axially oriented and caudally or cranially directed, as necessary . Branch position will be determined by the anatomic location of the target vessels using a consistent craniocaudal and circumferential cuff position.

Also known as: CMD-off-the-shelf branched devices-

Type I - III TAAA cohort

Arch cohort DEVICE

Arch branched devices may be designed using one of two configurations: (1) Zone 0 device with two inner antegrade branches for the innominate artery and the left common carotid artery with or without a retrograde left subclavian artery branch and (2) Zone 1-2 device with a single retrograde subclavian artery branch with double or triple wide scallop for the left common carotid artery. These devices are designed for a of proximal landing/fixation zone of at least 20 mm of healthy aortic segment or a previous graft.

Also known as: Zenith Arch Branch Device

Arch cohort

Eligibility Criteria

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

You may qualify if:

• Juxtarenal or suprarenal AAA, type I-IV thoracoabdominal aortic aneurysms or aortic arch aneurysms or dissections with diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter;
• Aneurysm with history of growth ≥0.5 cm/year;
• Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation.
• Patients that are not eligible for treatment with commercially available endografts.
• Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.

You may not qualify if:

• A patient must be excluded from the clinical investigation if any of the following are true:
• Age \<18 years;
• Life expectancy \<2 years;
• Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
• Inability or refusal to give informed consent by the patient or a legally authorized representative;
• Unwilling or unable to comply with the follow-up schedule;
• Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms, elephant trunk repair), to facilitate the procedure by allowing open reparation of a target artery not amenable to revascularization with the investigational device, such us an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement and alignment side stents, or to treat proximal aortic aneurysms.
• Participation in another clinical or device trial, with the exception of observational studies, participation in another investigational endovascular endograft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated/branched repair (\>30 days). Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated/branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
• Patients with ruptured aortic aneurysm requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.
• Patients who meet anatomical criteria for commercially available aortic stent-grafts according to proposed instructions for use of these devices.
• Patients must be excluded from the study if any of the following conditions are true:
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold
• History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated
• Leaking or ruptured aneurysm associated with hypotension
• Uncorrectable coagulopathy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9157, United States

Location

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

• Timaran LI, Timaran CH, Scott CK, Soto-Gonzalez M, Timaran-Montenegro DE, Guild JB, Kirkwood ML. Dual fluoroscopy with live-image digital zooming significantly reduces patient and operating staff radiation during fenestrated-branched endovascular aortic aneurysm repair. J Vasc Surg. 2021 Feb;73(2):601-607. doi: 10.1016/j.jvs.2020.05.031. Epub 2020 May 27.

  PMID: 32473339 DERIVED

• Timaran DE, Knowles M, Ali T, Timaran CH. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair. J Vasc Surg. 2017 Aug;66(2):354-359. doi: 10.1016/j.jvs.2016.11.064. Epub 2017 Feb 16.

  PMID: 28216359 DERIVED

• Timaran DE, Soto M, Knowles M, Modrall JG, Rectenwald JE, Timaran CH. Safety and effectiveness of total percutaneous access for fenestrated endovascular aortic aneurysm repair. J Vasc Surg. 2016 Oct;64(4):896-901. doi: 10.1016/j.jvs.2016.03.444. Epub 2016 May 27.

  PMID: 27237404 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: The study is divided in three groups, as follows: Patients with complex abdominal aortic aneurysms including, juxtarenal, suprarenal and type IV thoracoabdominal aneurysms will be enrolled in the fenestrated-CMD group. Patients with type I-III throacoabdominal aneurysms will be enrolled in the type I-III TAAAs groups and will be eligible for custom-made/ off-the-shelf branched devices. Patients with high surgical risk with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop.

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 17, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

US (1)