NCT00583817

Brief Summary

The purpose of this study is to assess the role endovascular therapy to treat aortic disease involving the ascending aorta, the aortic arch, and the visceral segment of the aorta (or thoracoabdominal aorta)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2018Dec 2030

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
10.8 years until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12.1 years

First QC Date

December 20, 2007

Last Update Submit

April 28, 2026

Conditions

Thoracic Aortic AneurysmsDissecting, AneurysmAscending Aorta AneurysmAortic Arch; Aneurysm, DissectingAscending Aortic DissectionThoracoabdominal Aortic AneurysmRenal Artery AneurysmSuperior Mesenteric Artery AneurysmAortic Dissection

Outcome Measures

Primary Outcomes (3)

  • All-cause mortality

    Freedom from death in perioperative and follow up time period

    5 years

  • Stroke and TIA

    Freedom from peri-operative neurologic event

    30 days

  • Aneurysm-related death

    Freedom from aneurysm death related to reintervention or incomplete repair

    5 years

Study Arms (3)

Ascending Aortic Arm

EXPERIMENTAL

Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.

Device: Endovascular stent-graft implantation

Arch Branch Arm

EXPERIMENTAL

Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.

Device: Endovascular stent-graft implantation

Thoracoabdominal Aortic Arm

EXPERIMENTAL

Investigational endovascular stent-graft implantation to exclude thoracoabdominal aortic pathology including aortic aneurysms, renal artery aneurysms, and superior mesenteric artery aneurysms.

Device: Endovascular stent-graft implantation

Interventions

Endovascular stent-graft implantationDEVICE

Endovascular repair of aorta: Patient-specific F/BEVAR treatment

Also known as: Arch Branched Device (Cook Medical), Helical Hypogastric Branched Device (Cook Medical), Ascending Aortic Endograft (Cook Medical), Patient-specific company manufactured Fenestrated/Branched Endovascular Device (Cook Medical)
Arch Branch ArmAscending Aortic ArmThoracoabdominal Aortic Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Life expectancy greater than 2 years
  • Suitable arterial anatomy
  • Absence of systemic disease or allergy that precludes an endovascular repair
  • Capable of giving informed consent and willingness to comply with follow up schedule
  • Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection
  • Have ONE of the following
  • Focal aneurysm in ascending aorta
  • Pseudoaneurysms and/or dissections that are distal to the sinotubular junction.
  • A thoracoabdominal aortic aneurysm ≥ 5.0 cm in women and ≥ 5.5 cm in men
  • Have morphology or growth suggestive of immanent rupture
  • Must meet ALL of the following:
  • Proximal Fixation:
  • \>15 mm aortic length distal to a patent coronary artery or coronary artery bypass that are considered patent and necessary for proper cardiac perfusion.
  • Proximal fixation may occur in either native aorta or surgical graft
  • In the setting of the aortic dissection, the proximal fixation must be proximal to the entry tear.
  • +72 more criteria

You may not qualify if:

  • Patient can be treated in accordance with the instructions for use with a commercially marketed endovascular prosthesis
  • Patient qualifies for treatment of thoracoabdominal aortic repair under an industry-sponsored clinical trial, open to enrollment at the Massachusetts General Hospital \& Brigham and Women's Hospital
  • Pregnancy
  • History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  • Known sensitivity or allergy to materials of construction of the device (including the materials of the LP device).
  • Body habitus that would inhibit X-ray visualization of the aorta
  • Subject had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \<30 days from the endovascular repair
  • Unstable angina
  • Unwilling to comply with follow up schedule
  • Systemic or local infection that may increase the risk of endovascular graft infection
  • An uncorrectable coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

  • 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: 39963789DERIVED

  • 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: 38989575DERIVED

  • 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: 37330702DERIVED

  • 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: 37059239DERIVED

  • Haulon S, Greenberg RK, Spear R, Eagleton M, Abraham C, Lioupis C, Verhoeven E, Ivancev K, Kolbel T, Stanley B, Resch T, Desgranges P, Maurel B, Roeder B, Chuter T, Mastracci T. Global experience with an inner branched arch endograft. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1709-16. doi: 10.1016/j.jtcvs.2014.02.072. Epub 2014 Feb 28.

    PMID: 24685375DERIVED

  • Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.

    PMID: 23809203DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic DissectionAneurysm, Ascending AortaAneurysmDissection, Ascending AortaAortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic SyndromeDissection, Thoracic AortaAortic Aneurysm, Abdominal

Study Officials

  • Matthew J Eagleton, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician Sponsor/PI

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

October 25, 2018

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(2)