PRESERVE-Zenith® Iliac Branch System Clinical Study

C

Cook Group

Status

Completed

Conditions

Aorto-iliac Aneurysms
Iliac Aneurysms

Treatments

Device: Endovascular repair for aortoiliac or iliac aneurysms.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01208415
05-625-P1

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Device Implant
Experimental group
Treatment:
Device: Endovascular repair for aortoiliac or iliac aneurysms.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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