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

William Cook Europe60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Aortic Dissection Involving the Descending Thoracic Aorta

Interventions

Zenith® Dissection Endovascular SystemDEVICE

Endovascular RepairDEVICE

Endovascular Repair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

St. Vincent's Hospital Melbourne

Melbourne, Australia

St. Anne's Universtiy Hospital Brno

Brno, Czechia

CHRU de Lille

Lille, Cedex, France

Hannover Medical School

Hanover, Germany

Outcomes

Primary Outcomes

The primary endpoint is survival at 30 days

Time frame: 30 days

Secondary Outcomes

Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.