Video

LINC 22: P-MAX Study with Dr Lichtenberg: ASPIREX®S Endovascular System

Published: 07 Jun 2022

  • Views:

    Views Icon 51
  • Likes:

    Heart Icon 0
View Transcript Download Transcript

Dr Michael Lichtenberg (Vascular Centre Clinic Arnsberg, DE) joins us at LINC 2022 to outline the findings of the P-MAX Study (NCT03116750), a post-market clinical follow-up to evaluate the safety and effectiveness of the ASPIREX®S Endovascular System (Straub Medical AG) in patients with deep vein thrombosis (DVT).

Discussion Points:
1. ASPIREX®S Endovascular System
2. Background of This Study
3. Study Design and Patient Population
4. Key Results
5. Recommended Use
6. Further Study Needed

Recorded on-site at LINC 2022, Leipzig.

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

Transcript

- Hello, my name is Michael Lichtenberg from Arnsberg Vascular Centre. I'm interventional angiologist, practicing in the arterial and venous field for many years now.

Studied Device in This Analysis

So the P-MAX study is a typical post-marketing study, analysing the safety and efficacy of the Aspirex thrombectomy system. So we are dealing with mechanical thrombectomy for different indications, analysing safety and efficacy for this device, including acute iliofemoral DVT, native iliofemoral DVT, in-stent DVT, and upper limb DVT.

Study Background

So the background is definitely the shift from catheter-directed thrombolysis in patients with acute thrombosis to a mechanical thrombectomy, meaning, with these new devices which we have now, like the Aspirex device, we have a very efficient tool to treat patients with acute DVT, but also a very safe tool, meaning we don't need any additional thrombolysis, meaning avoiding bleeding complication, long stay of the patient in the hospital, and no intensive care unit stay.

Study Design and Patient Population

So, 81 patients were treated in this post-marketing, multicenter prospective registry. So it was a very open registry, nearly no exclusion or inclusion criteria, therefore we can call it an all-comers registry, so every patient with acute or subacute iliofemoral DVT, upper limb DVT, could have been included in this trial, and that's why we were so successful to include so many patients in this registry.

Key Results

So the key results are very simple. Mechanical thrombectomy using the Aspirex device is very efficient and safe. So we did not have any bleeding complications, patient could be sent home very soon after the intervention, and we could remove significant amount of the thrombus in most of these patients, meaning technical success, and procedural success was close to 100% with the Aspirex mechanical thrombectomy device.

Further Study

So the next step is definitely to implement this mechanical thrombectomy more and more into daily routine practice. We are still seeing a lot of catheter-directed thrombolysis in the centers for treatment of acute iliofemoral DVT. Again, I don't think that CDT therapy is still an option in terms of efficacy and safety. We have very promising and effective mechanical thrombectomy devices on the market now.