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LINC 22: Cre8™ BTK Clinical Results in Complex BTK Patients

Published: 10 Jun 2022

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In this video recorded at LINC 22, Dr Marc Sirvent (Germans Trias i Pujol University Hospital, ES) joins us to discuss the clinical results of the Cre8™ BTK Study, which aimed to evaluate the safety and efficacy of Alvimedica's Cre8™ drug-eluting stent in complex patients undergoing below-the-knee surgery. 

Discussion Points:
1. Reasoning Behind This Study
2. Patient Population and Study Design
3. Key Findings
4. Conclusions
5. Take-Home Messages For Clinicians

Recorded on-site at LINC 2022, Leipzig.


Interviewer: Mirjam Boros
Editor: Jordan Rance
Videography: Tom Green

Transcript

- I am Marc Sirvent. I am a vascular surgeon from Barcelona. I am working at Hospital University German Trias. in Pujol for uh, six years.

Study Reasoning

Well, evidence shows us that drug-eluting stents work very well in the below-the-knee vessels, even are the best option in the short lesions. We have been using drug-eluting stents in this area for many years and wanted to check, to verify, to audit our results in our population. This is the reason why we started this trial. On the other hand, we had a feeling that the CRE8™ works amazingly well in this area but we needed to verify this feeling was right or not. And it was right.

Patient Population and Study Design

This is a prospective single centre registry to evaluate the safety and efficacy of the Cre8™ stent in our population, which is 100% critical limb ischemia. More or less 90% ready for class 4, 5 or 6 and 10% are ready for class 4 It means rest pain.

Key Findings

The key findings is that, that the Cre8™ works ultimately well in this complex, these complex patients with long term follow up. So we have, we stented lesions up to 13 centimetres in length, with 4 Cre8s™. We have two years primary patency of more than 80%. We have two years limb salvage delayed of nearly 96%. And we have healed ulcer rate of 95%. So we have different patients with three years follow up. So I think these are these are excellent results with long term follow-up.

Conclusions

Firstly, I would say drug-eluting stents are a very good option in short and medium lesions. And secondly, and this is my approach; it's my personal approach, a Cre8™ for me is the best stent to place and to treat these vessels because of its excellent results and due to its distinctive technologies. So the, in this way we consider Cre8™ not only for the bill of situation, as recoil, or flow-limiting sanctions but also as a primary indication when we face short, medium occlusions in the proximal part of the, below-the-knee vessels.

Take-Home Messages

Don't be afraid to use these stents in the below in the below-the-knee vessels because they are safe and have very good results. And beside the concerns about the to live a permanent implant there in most of the cases, I can say in most cases of their intervention, we found the proximal and distal disease progression but with patent stents. And so, which makes intervention easier.