Zenith® Dissection Endovascular System

N/ACompletedNCT02094300

Cook Group Incorporated26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Dissection

Interventions

Zenith® Dissection Endovascular GraftDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of Florida

Gainesville, Florida, United States

Massachusetss General Hospital

Boston, Massachusetts, United States

Cooper University Hospital

Camden, New Jersey, United States

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of Patients With Major Complications

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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