Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

NCT ID: NCT02464943

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Dissection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular Treatment (Zenith)

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endovascular graft Endovascular stent Stent-graft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* \< 18 years of age
* Other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., \< 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
* Unwilling to unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cook Research Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cooper University Hospital

Camden, New Jersey, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-007-CA

Identifier Type: -

Identifier Source: org_study_id

NCT02418611

Identifier Type: -

Identifier Source: nct_alias

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.