Zenith® Dissection Endovascular System (STABLE I)

Cook Group

Status: Completed

Conditions: Aortic Dissection

Treatments: Device: Zenith® Dissection Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094300

05-622

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Endovascular

Experimental group

Treatment:

Device: Zenith® Dissection Endovascular Graft