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Kirkwood M, Armstrong EJ, Ansari MM, Holden A, Reijnen MM, Steinbauer M, Crannell Z, Novoa H, Phillips A, Schneider DB
FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
FORWARD Study: Protocol for a Prospective, Randomized Superiority Trial of GORE® VIABAHN® Balloon-Expandable Endoprostheses and Bare Metal Stents
Melissa Kirkwood;
Ehrin J. Armstrong;
Mohammad M. Ansari;
Andrew Holden;
Michel M.P.J. Reijnen;
Markus Steinbauer;
Zachary Crannell;
Hector Novoa;
Austin Phillips;
Darren B. Schneider
ABSTRACT
Background:
The recommendations for the use of and selection of covered stent-grafts in patients with aortoiliac occlusive disease is limited.
Objective:
The GORE VBX FORWARD Clinical Study is designed to demonstrate the superiority of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease.
Methods:
A prospective, multicenter, randomized control study in United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 to 10 cm in length. Patients will be randomized to treatment with the VBX device or commercially available BMS. The primary endpoint is 12 month primary patency and will be adjudicated by an independent imaging core laboratory and clinical events committee. Key secondary endpoints will be tested for superiority and include cumulative reintervention rate, difference in mean ankle-brachial index, and freedom from target lesion revascularization. Study follow-up will continue through 5 years.
Results:
Outcomes will be reported following study completion.
Conclusions:
The results of this study will provide definitive, level-one clinical evidence to clinicians on the optimal choice of stent device to use for treatment of complex iliac artery occlusive disease. Clinical Trial: ClinicalTrials.gov; NCT05811364
Citation
Please cite as:
Kirkwood M, Armstrong EJ, Ansari MM, Holden A, Reijnen MM, Steinbauer M, Crannell Z, Novoa H, Phillips A, Schneider DB
FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial