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

William Cook

Status: Completed

Conditions: Aortic Dissection Involving the Descending Thoracic Aorta

Treatments: Device: Endovascular Repair; Device: Zenith® Dissection Endovascular System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00526487

07-004

370010, TXD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Other group

Description:

Endovascular Repair

Treatment:

Device: Endovascular Repair

Device: Zenith® Dissection Endovascular System