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

NCT02464943 | Unknown

• 1 other identifier: 11-007-CA
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Dissection

Keywords

Aorta; Thoracic; Aortic dissection; Type B; DeBakey type III; Endovascular

Interventions

Endovascular Treatment (Zenith) DEVICE

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.

Also known as: Endovascular graft, Endovascular stent, Stent-graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (3)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Aortic Dissection

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (3)