Zenith® Dissection Endovascular System

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.

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Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Cardiovascular Diseases Dissection, Blood Vessel Rupture Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Branch vessel obstruction/compromise
Peri-aortic effusion/hematoma
Resistant hypertension
Persistent pain/symptoms
Transaortic growth >5 mm within 3 months
Transaortic diameter >40 mm.

Exclusion criteria

Age <18 years;
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., less than 2 years)
Pregnant, breast-feeding, or planning on becoming pregnant within 24 months;
Unwilling or 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.)
Additional medical restrictions as specified in the Clinical Investigation Plan, or
Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Treatment and study plan

Zenith® Dissection Endovascular Graft

Device

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

Other names: Endovascular graft, Stent-graft

Primary outcomes

Number of Patients With Major Complications

Time frame: 30 days

Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Acronym: STABLE I

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2016
First posted: Mar 21, 2014
Registry last updated: Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed