Title screen (00:00):
Zenith® Iliac Branch
5-year outcomes of the PRESERVE II Clinical Trial
W. Anthony Lee, MD
Principal Investigator, PRESERVE II Clinical Trial
Chief of Vascular Surgery
Christine E. Lynn Heart and Vascular Institute
Boca Raton, Florida

Onscreen disclaimer:
The content, information, opinions, and viewpoints contained in this video are for educational purposes only, and speakers are paid consultants for Cook Medical. Some opinions expressed may represent those of the speaker and are based on their own clinical experience in their practice. This information is not meant or intended to serve as a substitute for a healthcare professional’s clinical training, experience, or judgment. Always refer to the Instructions for Use (IFU) for complete prescribing information including indications for use, warnings, precautions, adverse events, and deployment/use instruction.

Dr. Lee (00:13):
Over the last few years, I’ve had the distinct privilege of being the national PI for the PRESERVE II Clinical Trial.

Slide onscreen (00:21):
What are the most significant outcomes of the PRESERVE II trial?

Dr. Lee (00:26):
Well, the highlights of the PRESERVE II trial can really be summarized by the fact that it not only met but exceeded its primary and secondary endpoints, namely the primary endpoint being patency-related secondary interventions, which was met in 100% of the subjects enrolled.

Onscreen text:
Primary and secondary endpoints include:¹
6-month freedom from patency-related interventions was 100%
6-month branch vessel patency was 100%

Dr. Lee (00:48):
I would also like to emphasize that these results have been maintained through the five-year follow-up, which really speaks to the durability of these outcomes.

Slide onscreen (01:01):
With options on the market, what factors into your choice of a Cook device over a Gore device?

Dr. Lee (01:07):
Both devices largely have similar functionalities, but there are substantive physical differences between the two systems that I would like to highlight. First of all, the proximal diameter of the two devices are vastly different. In the Cook IBD device, it’s 12 mm, versus 23 mm of the Gore IBE device. This actually has some relevance in certain anatomies where the proximal portion of the iliac aneurysm can be somewhat narrowed.

The second difference is the Cook IBD device is offered in two main body lengths. In cases where the actual iliac aneurysm is relatively short, this is a very convenient feature, especially in terms of actually deploying this device and accessing from the contralateral side such that the top portion of the endograft does not protrude too much into the aortic aneurysm itself.

Furthermore, the actual iliac branch is also shorter and smaller, and this also impacts the deployment. This once again is an important feature in the context of short common iliac artery aneurysms, where the branch can be positioned extremely closely, right at the opening of the hypergastric artery.

Slide onscreen:
What are the challenges of mixing and matching different company devices?

Dr. Lee (02:46):
But one must keep in mind the outcomes that were obtained and shown in clinical trials, such as the PRESERVE II, really pertain to using the same manufacturer’s devices and staying within the IFU.

Transcript table of contents

• 0:00 | Intro and disclaimers
• 00:21 | Significant outcomes of the PRESERVE II trial
• 01:01 | Choosing Cook vs. Gore devices
• 02:41 | Mixing and matching different company devices