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.
Brief Title
Zenith® Dissection Clinical Trial
Completion Date
Completion Date Type
Actual
Conditions
Aortic Dissection
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Keywords
Aorta
Thoracic
Aortic dissection
Rupture
Type B
DeBakey type III
Endovascular
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01568320
Org Class
Industry
Org Full Name
Cook Group Incorporated
Org Study Id
11-007
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
Primary Outcomes
Outcome Description
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
Outcome Measure
Number of Participants With Freedom From Major Adverse Events
Outcome Time Frame
30 days
Outcome Description
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Outcome Measure
Survival Rate at 30 Days
Outcome Time Frame
30 days
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Evan Lipsitz
Investigator Email
elipsitz@montefiore.org
Investigator Phone