Aortic Dissection
Conditions
Keywords
Aorta, Thoracic, Aortic dissection, Rupture, Type B, DeBakey type III, Endovascular
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 acute, complicate Type B aortic dissection.
Interventions
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.
Sponsors
Cook Research Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Major Adverse Events | 30 days | 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 |
| Survival Rate at 30 Days | 30 days | Primary effectiveness endpoint is freedom from all cause mortality at 30 days |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): 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. | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to open repair | 1 |
| Overall Study | Death | 20 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Patient fell outside of the consented window, data outside of the consented 5-year was not collected | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Endovascular |
|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 73 |
| other Total, other adverse events | 40 / 73 |
| serious Total, serious adverse events | 63 / 73 |
Outcome results
Primary
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
Population: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment).Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular | Number of Participants With Freedom From Major Adverse Events | 48 participants |
95% CI: [59, 82]
Primary
Survival Rate at 30 Days
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Time frame: 30 days
Population: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment). Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular | Survival Rate at 30 Days | 64 participants |
95% CI: [87, 99]