- 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.
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.
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.
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.