Zenith® TX2® Low Profile TAA Endovascular Graft

NCT ID: NCT02471781

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.

Detailed Description

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Conditions

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Aortic Aneurysm Penetrating Ulcer Vascular Disease

Interventions

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Zenith TX2 Low Profile TAA Endovascular Graft

Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.

Intervention Type DEVICE

Other Intervention Names

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Zenith Alpha Thoracic™ Endovascular Graft

Eligibility Criteria

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Inclusion Criteria

* Meets one of the following

* Descending thoracic aneurysm with diameter ≥ 5.0 cm
* Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
* Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria

* Life expectancy less than 2 years
* Pregnant of breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Less than 30 days beyond primary endpoint for other investigative drug or device study
* Receiving home oxygen
* Myocardial infarction within the last 3 months
* Stroke within the last 3 months
* Diagnosed or suspected congenital degenerative collagen disease
* Systemic infection
* Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
* Allergy to polyester, polypropylene, nitinol, or gold
* Previous placement of a thoracic endovascular graft
* Prior open repair involving the descending thoracic aorta
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Illig, MD

Role: PRINCIPAL_INVESTIGATOR

Dialysis Access Center

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

Site Status

Indiana Heart Hospital

Indianapolis, Indiana, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Cooper University Hospital

Camden, New Jersey, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

The Mount Sinai Hospital

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-001 CA

Identifier Type: -

Identifier Source: org_study_id

NCT02319551

Identifier Type: -

Identifier Source: nct_alias

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