PRESERVE-Zenith® Iliac Branch System Clinical Study

N/ACompletedNCT01208415

Cook Group Incorporated40 enrolled

Overview

The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aorto-iliac Aneurysms Iliac Aneurysms

Interventions

Endovascular repair for aortoiliac or iliac aneurysms.DEVICE

Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * An aortoiliac or iliac aneurysm of appropriate size * Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery Exclusion Criteria: * Less than 18 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Unsuitable arterial anatomy

Locations (19)

VA Palo Alto HCS

Palo Alto, California, United States

Stanford University Medical Center

Stanford, California, United States

Outcomes

Primary Outcomes

Patients That Are Free From Patency-related Intervention

Patency-related intervention is defined as: Secondary intervention to treat a \> 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.

Time frame: 6 Months

Data from ClinicalTrials.gov

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