Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms

NCT02264977 | Completed Results DMC

• 1 other identifier: SSB 11-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to assess the early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch

Conditions

Aneurysm of Aortic Arch

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Successful Study Device Access

  Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.

  During treatment procedure (day 0)

• Number of Participants With Successful Study Device Deployment

  Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.

  During treatment procedure (day 0)

• Number of Participants With Primary Procedural Side Branch Patency

  The presence of forward flow through the implanted Side Branch Component into the target branch vessel.

  At conclusion of the treatment procedure (day 0)

Secondary Outcomes (2)

• Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab

  1 Month

• Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab

  1 Month

Study Arms (1)

Branched TAG® Device

EXPERIMENTAL

Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis

Device: GORE® TAG® Thoracic Branch Endoprosthesis

Interventions

GORE® TAG® Thoracic Branch Endoprosthesis DEVICE

Branched TAG® Device

Eligibility Criteria

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

You may qualify if:

• Presence of aortic aneurysm involving the aortic arch deemed to warrant surgical repair which requires proximal graft placement in Zone 0 or Zone 1:
• Fusiform (≥ 55 mm), or
• Fusiform (\>2 times native aortic diameter), or
• Saccular (no diameter criteria)
• Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator
• Age ≥18 years at time of informed consent signature
• Subject is capable of complying with protocol requirements, including follow-up
• Informed Consent Form (ICF) is signed by Subject or legal representative
• Must have appropriate proximal aortic landing zone, defined as:
• Acceptable proximal landing zone outer curvature length for the required device
• Landing zone inner diameters between 16-48 mm in Zone 1 Subjects and 24-48mm in Zone 0 Subjects
• Landing zone, which must include either the brachiocephalic or left common carotid native ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed
• Must have appropriate distal aortic landing zone, defined as:
• Outer curvature length must be ≥2cm proximal to the celiac artery
• Aortic inner diameters between 16-48 mm (diameter must be between 16-42mm if using distal TAG® Device extension)

You may not qualify if:

• Concomitant aneurysm/disease of the ascending aorta, or abdominal aorta requiring repair
• Previous endovascular repair of the ascending aorta
• Previous endovascular repair of the DTA with a non-Gore device
• Surgery within 30 days of treatment
• Infected aorta
• Dissection of the aorta
• Intramural hematoma of the aortic arch or DTA without aneurysm
• Life expectancy \<2 years
• Myocardial infarction or stroke within 6 weeks prior to treatment
• Patient has a systemic infection and may be at increased risk of endovascular graft infection
• Pregnant female at time of informed consent signature
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within one year of study enrollment
• Known history of drug abuse within one year of treatment
• Significant thrombus or atheroma in the aortic arch

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (6)

Leland Stanford Junior University

Stanford, California, 94305-5407, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)

Lebanon, New Hampshire, 03756, United States

Location

Hospital at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Univerisity of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Jennifer Gorman
• Organization: W.L. Gore & Associates

jgorman@wlgore.com

928-863-8483

Study Officials

• Michael D Dake, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: March 1, 2022
• Last Updated: September 14, 2022
• Results First Posted: August 2, 2017

Record last verified: 2022-08

Locations

US (6)