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 patients with aortic dissection.
Interventions
DEVICEZenith® Dissection Endovascular Graft
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.
Sponsors
Cook Group 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Dissection Endovascular Graft The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Still be eligible for follow-up | 3 |
Baseline characteristics
| Characteristic | Zenith® Dissection Endovascular Graft |
|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 15 |
| Gender Female | 7 Participants |
| Gender Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 26 |
| serious Total, serious adverse events | 2 / 26 |
Outcome results
Primary
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
Population: There were 8 patients experienced 30-day major complications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zenith® Dissection Endovascular Graft | Number of Patients With Major Complications | Paralysis or paraparesis unresolved after 30 days | 2 participants |
| Zenith® Dissection Endovascular Graft | Number of Patients With Major Complications | Stroke | 4 participants |
| Zenith® Dissection Endovascular Graft | Number of Patients With Major Complications | Retrograde Type A dissection | 2 participants |
| Zenith® Dissection Endovascular Graft | Number of Patients With Major Complications | Renal failure requiring dialysis | 3 participants |
| Zenith® Dissection Endovascular Graft | Number of Patients With Major Complications | Prolonged ventilation requiring tracheotomy | 3 participants |