Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT02464943

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Device: Endovascular Treatment (Zenith)

Study Design

Study Type:

Expanded Access

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Exclusion Criteria:

< 18 years of age
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., < 2 years)
Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
Unwilling to 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cooper University Hospital	Camden	New Jersey	United States	08103
2	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
3	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908