Zenith® Dissection Clinical Trial

Cook Research Incorporated73 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 acute, complicate Type B aortic dissection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Dissection

Interventions

Endovascular Treatment (Zenith)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Exclusion Criteria: 1. Age \< 18 years; 2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years); 3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4. Unwilling or unable to comply with the follow-up schedule; 5. Inability or refusal to give informed consent; 6. 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.); 7. Additional medical restrictions as specified in the Clinical Investigation Plan; or 8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Locations (24)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of Participants With Freedom From Major Adverse Events

Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support

Time frame: 30 days

Survival Rate at 30 Days

Primary effectiveness endpoint is freedom from all cause mortality at 30 days

Time frame: 30 days

Data from ClinicalTrials.gov

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