Clinical trial NCT00526487: Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Dissection Involving the Descending Thoracic Aorta
Keywords: Thoracic Dissection
Dissection
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Cook Group Incorporated
name: MED Institute, Incorporated
name: William Cook Australia
First posted: 2007-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is survival at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
city: Brno
country: Czech Republic
facility: St. Anne's Universtiy Hospital Brno
city: Lille
country: France
facility: CHRU de Lille
state: Cedex
city: Hannover
country: Germany
facility: Hannover Medical School
city: Leipzig
country: Germany
facility: Heart Center Leipzig / Park Hospital
city: Rostock
country: Germany
facility: Clinic of Internal Medicine, University Hospital Rostock
city: Milan
country: Italy
facility: Hospital San Raffaele
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
Study officials:
affiliation: Thomas Jefferson University
name: Joseph Lombardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.