Sam Brusco, Associate Editor06.13.23
W.L. Gore & Associates (Gore) has begun its Gore VBX FORWARD clinical study to compare its VBX stent graft to bare metal stenting for complex iliac occlusive disease.
The trial will take place at up to 40 sites in the U.S., Australia, New Zealand, and Europe. An estimated 244 subjects will be randomized 1:1 to the VBX stent graft group or control group and will have follow-up visits up to five years hence.
The primary endpoint is primary patency through a year. Secondary endpoints will address technical success, acute procedural success, clinical success, further patency, and target lesion revascularization outcomes and patient improvement metrics. One-year results are anticipated in 2027.
"There is limited randomized long-term head-to-head outcomes data available to guide stent choice for the treatment of iliac occlusive disease. The VBX FORWARD Study represents an opportunity to positively impact practice guidelines in this area. I look forward to seeing and sharing the data on the full range of clinical scenarios where the VBX Stent Graft may offer an advantage over bare metal stents," Melissa Kirkwood, M.D., Professor and Chief of Vascular Surgery, University of Texas Southwestern Medical Center, Dallas, Texas and VBX FORWARD Study Steering Committee Member, told the press.
"Iliac occlusive disease can be challenging to treat, with tortuous anatomy, severe stenosis and calcified occlusions presenting treatment risks such as perforation and rupture. Covered stents are an integral tool for decreasing the risk of complications in these complex cases and delivering durable outcomes, and the VBX FORWARD Study is thoughtfully designed to further explore those advantages," added Prof. Dr. Michel M.P.J. Reijnen, Vascular Surgeon, Rijnstate Arnhem, The Netherlands and VBX FORWARD Study Steering Committee Member.
The VBX stent graft was developed using the small-diameter, ePTFE stent graft technology from the GORE VIABAHN endoprosthesis. It’s available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm.
Gore also began enrollment for its VIAFORT vascular stent iliofemoral study last week.
The trial will take place at up to 40 sites in the U.S., Australia, New Zealand, and Europe. An estimated 244 subjects will be randomized 1:1 to the VBX stent graft group or control group and will have follow-up visits up to five years hence.
The primary endpoint is primary patency through a year. Secondary endpoints will address technical success, acute procedural success, clinical success, further patency, and target lesion revascularization outcomes and patient improvement metrics. One-year results are anticipated in 2027.
"There is limited randomized long-term head-to-head outcomes data available to guide stent choice for the treatment of iliac occlusive disease. The VBX FORWARD Study represents an opportunity to positively impact practice guidelines in this area. I look forward to seeing and sharing the data on the full range of clinical scenarios where the VBX Stent Graft may offer an advantage over bare metal stents," Melissa Kirkwood, M.D., Professor and Chief of Vascular Surgery, University of Texas Southwestern Medical Center, Dallas, Texas and VBX FORWARD Study Steering Committee Member, told the press.
"Iliac occlusive disease can be challenging to treat, with tortuous anatomy, severe stenosis and calcified occlusions presenting treatment risks such as perforation and rupture. Covered stents are an integral tool for decreasing the risk of complications in these complex cases and delivering durable outcomes, and the VBX FORWARD Study is thoughtfully designed to further explore those advantages," added Prof. Dr. Michel M.P.J. Reijnen, Vascular Surgeon, Rijnstate Arnhem, The Netherlands and VBX FORWARD Study Steering Committee Member.
The VBX stent graft was developed using the small-diameter, ePTFE stent graft technology from the GORE VIABAHN endoprosthesis. It’s available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm.
Gore also began enrollment for its VIAFORT vascular stent iliofemoral study last week.