Zenith® Dissection Endovascular System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2016-11-30

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zenith® Dissection Clinical Trial

NCT01568320

Aortic Dissection

COMPLETED NA

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

NCT02464943

Aortic Dissection

APPROVED_FOR_MARKETING

Zenith® Fenestrated+ Clinical Study

NCT04875429

Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Extent IV Thoracoabdominal +1 more

ACTIVE_NOT_RECRUITING NA

TRANSFIX Zenith® Transection Clinical Study

NCT01688050

Thoracic Aorta Thoracic Injuries Blunt Injuries

COMPLETED NA

Zenith® p-Branch® Endovascular Graft Pivotal Study

NCT02396199

Aortic Aneurysm Abdominal

COMPLETED NA

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endovascular

Group Type EXPERIMENTAL

Zenith® Dissection Endovascular Graft

Intervention Type 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.

Interventions

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

Zenith® Dissection Endovascular Graft

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.

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 Stent-graft

Eligibility Criteria

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No