Zenith® Dissection Endovascular System
- Conditions
- Aortic Dissection
- Interventions
- Device: Zenith® Dissection Endovascular Graft
- Registration Number
- NCT02094300
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- Branch vessel obstruction/compromise
- Peri-aortic effusion/hematoma
- Resistant hypertension
- Persistent pain/symptoms
- Transaortic growth >5 mm within 3 months
- Transaortic diameter >40 mm.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular Zenith® Dissection Endovascular Graft -
- Primary Outcome Measures
Name Time Method Number of Patients With Major Complications 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
University of Florida
🇺🇸Gainesville, Florida, United States
Massachusetss General Hospital
🇺🇸Boston,, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadephia, Pennsylvania, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States