Aneurysm of Aortic ArchNCT02264977

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

A study testing GORE® TAG® Thoracic Branch Endoprosthesis in people with Aneurysm of Aortic Arch, run by W.L.Gore & Associates at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aneurysm of Aortic Arch
What is being tested?: GORE® TAG® Thoracic Branch Endoprosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 6 sitesUnited States
Study dates: Apr 2015to Mar 2022
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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:
Must require placement of the proximal extent of the Aortic Component in Zone 0 or Zone 1 for exclusion of the lesion
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)
Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
Landing zone in native aorta or previously implanted GORE® TAG® Device
Must have appropriate target branch vessel landing zone, defined as:
Length of ≥3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter, or length of ≥2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects)
Target branch vessel inner diameters of 6-15 mm if using Aortic Component with 8mm portal diameter, or inner diameters of 11-18 mm if using Aortic Component with 12mm portal diameter (required for Zone 0 Subjects)
Target branch vessel landing zone must be in native aorta that cannot be aneurysmal, heavily calcified, or heavily thrombosed

Who cannot join

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

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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
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of Michigan
Ann Arbor, Michigan, 48109
The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)
Lebanon, New Hampshire, 03756
Hospital at University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Leland Stanford Junior University
Stanford, California, 94305-5407

Other trials in United States

About this study

Official title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (Branched TAG® Device) in the Treatment of Aortic Arch Aneurysms

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

Read the detailed description

The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular treatment options for patients with aortic arch aneurysms are limited as current stent graft technology would require coverage of aortic arch vessels. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was being evaluated under IDE G130120 for Zone 2 aneurysms when this clinical investigation was initiated to evaluate the GORE® TAG® Thoracic Branch Endoprosthesis for the treatment of Zone 0 and Zone 1 aneurysms of the aortic arch.

Conditions: Aneurysm of Aortic Arch
Being tested: GORE® TAG® Thoracic Branch Endoprosthesis
Medical subject headings: Aneurysm, Aortic Arch

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® TAG® Thoracic Branch EndoprosthesisDevice

Study groups in NCT02264977
Study group	Role	What they receive
Branched TAG® Device	Experimental	Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 Month
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (Type IA or IB) or the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (Type III).
Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Mar 2022

First posted15 Oct 2014 (estimated)
Study startApr 2015
Primary completionJul 2016
Study completionMar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aneurysm of Aortic ArchStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02264977
Sponsor's protocol ID: SSB 11-03
Status last verified: Aug 2022
First submitted: 8 Oct 2014
Last updated: 14 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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