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NCT02464943 Clinical Trial

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

Aortic Dissection Clinical Trial

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT02464943
Other study ID # 11-007-CA
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date January 2020
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Other known NCT identifiers
  • NCT02418611

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

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
United States Cooper University Hospital Camden New Jersey
United States University of Virginia Medical Center Charlottesville Virginia
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

See also
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Recruiting NCT02201589 - Feasibility of Endovascular Repair Of Ascending Aortic Pathologies N/A
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Enrolling by invitation NCT05912608 - Optimal Strategy for Repair of Type A Acute Aortic Dissection
Recruiting NCT03707743 - Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)
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Not yet recruiting NCT06044259 - Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection N/A
Completed NCT05039814 - Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
Recruiting NCT03780738 - A Validation Study of The Relationship Between ALDH2 and Aortic Dissection
Completed NCT03647566 - 18F Sodium Fluoride PET/CT in Acute Aortic Syndrome
Enrolling by invitation NCT05800743 - Evaluation of the GORE® Ascending Stent Graft N/A
Recruiting NCT03347812 - Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair N/A
Completed NCT05044494 - Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
Terminated NCT02958098 - My Research Legacy Pilot Study