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Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00526487
Enrollment
60
Registered
2007-09-10
Start date
2007-12-31
Completion date
2016-09-30
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection Involving the Descending Thoracic Aorta

Keywords

Thoracic Dissection, Dissection, Endovascular

Brief summary

The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

Detailed description

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

Interventions

DEVICEZenith® Dissection Endovascular System

The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.

DEVICEEndovascular Repair

Endovascular Repair

Sponsors

Cook Group Incorporated
CollaboratorINDUSTRY
MED Institute, Incorporated
CollaboratorINDUSTRY
William Cook Australia
CollaboratorINDUSTRY
William Cook Europe
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Branch vessel obstruction/compromise * Peri-aortic effusion/hematoma * Resistant hypertension * Persistent pain/symptoms * Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion criteria

* Age less than 18 years * Frank rupture * Diagnosed or suspected congenital degenerative connective tissue disease * Systemic infection * Untreatable reaction to contrast * Surgical/endovascular AAA repair within 30 days * Previous placement of thoracic endovascular graft * Prior repair of descending thoracic aorta * Interventional/open procedures within 30 days * Onset of symptoms \> 3 months

Design outcomes

Primary

MeasureTime frame
The primary endpoint is survival at 30 days30 days

Secondary

MeasureTime frame
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity12 months

Countries

Australia, Czechia, France, Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026