Zenith® Dissection Clinical Trial

Aortic Dissection Clinical Trial

Official title:

Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568320
• Other study ID #: 11-007
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: January 27, 2020

Study information

• Verified date: February 2021
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 27, 2020
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Japan	Jikei University School of Medicine	Tokyo
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	The Christ Hospital	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Methodist Hospital	Houston	Texas
United States	Indiana Heart Hospital	Indianapolis	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	New York University Hospital	New York	New York
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Washington-Harborview Medical Center	Seattle	Washington
United States	University of South Florida	Tampa	Florida
United States	Scott and White Hospital	Temple	Texas
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	30 days
Primary	Survival Rate at 30 Days	Primary effectiveness endpoint is freedom from all cause mortality at 30 days	30 days