IGUIDEU Clinical Trial

Global, prospective, multi-center, randomized controlled trial. After signing a written informed consent, patients will be randomized 1:1 to either a deferred-interrogation group or to an interrogation group in which patients will be first evaluated with MPV imaging during iliac common femoral vein assessment for possible endovascular intervention and then further interrogated with IVUS imaging. The treatment plan derived from venography alone will be compared to the treatment plan created with the addition of the IVUS information and any
differences in treatment plan will be documented. Confirmation of whether or not the threshold of stenosis/occlusion required for endovenous stenting has been met will be determined by the IVUS imaging obtained. Any patients determined to require venous stenting will be stented according to the on-label manufacturer’s instructions for the use of IVUS in guiding stent sizing
and placement.

Company’s Keywords:

venous wounds, venous leg ulcers, ceap6 patients, ivus, vascular surgery