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

Not Applicable

Completed

• Conditions: Aortic Dissection Involving the Descending Thoracic Aorta
• Interventions: Device: Zenith® Dissection Endovascular System; Device: Endovascular Repair

• Registration Number: NCT00526487
• Lead Sponsor: William Cook Europe

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.

Study Timeline

• Study First Submitted: 2007-09-05
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Study Start: 2007-12
• Primary Completion: 2011-07
• Study Completion: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Endovascular Repair	Endovascular Repair
1	Zenith® Dissection Endovascular System	Endovascular Repair

Primary Outcome Measures

Name	Time	Method
The primary endpoint is survival at 30 days	30 days

Secondary Outcome Measures

Name	Time	Method
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity	12 months

Trial Locations

Locations (8)

Hannover Medical School; 🇩🇪 Hannover, Germany

Hospital San Raffaele; 🇮🇹 Milan, Italy

CHRU de Lille; 🇫🇷 Lille, Cedex, France

Clinic of Internal Medicine, University Hospital Rostock; 🇩🇪 Rostock, Germany

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

St. Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Australia

St. Anne's Universtiy Hospital Brno; 🇨🇿 Brno, Czech Republic

Heart Center Leipzig / Park Hospital; 🇩🇪 Leipzig, Germany