W L Gore & Associates (Gore) has announced the completion of target enrolment in the EXPAND postmarket Registry of the Gore Viabahn VBX balloon-expandable endoprosthesis (VBX stent graft).
A press release details that 280 patients at 15 European sites have been enrolled to collect safety and performance data of the VBX stent graft to evaluate how the device performs in real-world cases.
This prospective, multicentre registry offers an opportunity to understand the varied usages for the VBX stent graft to treat different pathologies in a wide range of anatomical locations. These include lesion exclusion (non-iatrogenic, such as aneurysmatic disease, or iatrogenic, inclusive of ruptures or perforation), visceral perfusion (including fenestrated/branched bridging stent), luminal reconstruction (arteriovenous fistulas) or occlusive disease with the exception of de novo iliac occlusive disease. De novo iliac occlusive disease was already captured in the Gore VBX FLEX clinical study, which reported robust procedural success and durable clinical outcomes through three years, with 96.9% primary patency at nine months and 91.2% freedom from target lesion revascularisation (TLR) at three years.
“Currently we do not have real-world data to evaluate the variety of covered balloon-expandable devices in the different anatomies. Using EXPAND to understand the safety and performance of the VBX stent graft in these anatomical locations, alongside the VBX FLEX trial, is key to determining future treatment options for our vascular patients with this device”, said Mauro Gargiulo (IRCCS S Orsola Hospital, Bologna, Italy), principal investigator of the registry.
Patients enrolled in the EXPAND registry will be followed for five years, with a primary endpoint evaluating procedural success and freedom from VBX stent graft-related serious adverse event at 30 days, and secondary endpoints on safety and efficacy through five years.
“The EXPAND registry will help us advance our patient care and improve our clinical outcomes based on the long-term real-world evidence it will provide”, commented Martin Austermann of St Franziskus Hospital in Münster, Germany, the site that has enrolled the highest number of patients. “Of considerable appeal is evaluating the use of the VBX stent graft as a bridging stent for complex aortic fenestrated and branched endovascular repair,” continued Austermann.
According to a company press release, the Gore Viabahn VBX balloon-expandable endoprosthesis offers precise delivery and supports positive outcomes in complex aortoiliac applications. Gore advises that the device is available in a range of diameters from 5–11mm and lengths of 15, 19, 29, 39, 59 and 79mm.