Self-expanding nitinol stents of high versus low chronic outward force in de novo femoropopliteal occlusive arterial lesions (BIOFLEX-COF trial): study protocol for a randomized controlled trial

The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions.MethodsThe BIOFLEX-COF trial is a prospective, quantitative, randomized study. Eighty subjects with symptomatic peripheral arterial lesions eligible for endovascular stent implantation will be enrolled and randomly assigned to either a high COF group (LifeStent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) or low COF group (Pulsar, Biotronik AG, B ülach, Switzerland) using an online randomization program to generate a random 1:1 group allocation (block randomization). After implantation and dilatation, COF at every 2 mm along the stent axis will be calculated from the actual stent diameter versus its nominal diameter.There will be two follow-up evaluations at 12 and 24 months. Primary endpoint is the amount of in-stent neointima at 1 year, assessed by contrast-enhanced CT angiography (CTA). In the control examinations, stent diameter and true lumen diameter will be measured on DICOM images every 2 mm along the stent axis to quantify the relative amount of in-stent restenosis.Secondary objectives are the amount of in-stent neointima at 2 years, device- and procedure-related adverse events and target lesion revascularization (TLR) rate.The scheduled time for recruitment is 2 years. Recruitment is expected to be complet...
Source: Trials - Category: Research Source Type: clinical trials