Belgian Trial Evaluating the ClearLumen II Peripheral Thrombectomy System Recanalization of (sub)acute Thrombotic Femoropopliteal Occlusions

Overview

The BELTHROM trial investigates the efficacy and safety of the ClearLumen II Peripheral Thrombectomy System recanalization of acute and subacute thrombotic femoropopliteal occlusions (Acute Limb Ischemia (ALI); Rutherford I, IIa, IIb and III). An expected total of 50 patients will be treated. The lesion is located within the femoropopliteal artery (native, in-stent or bypass graft). During the procedure, the device is introduced, activated and slowly advanced into the occlusion to clean out the wall-adherent thrombotic material. If residual underlying stenosis of \>30% persists additional endovascular treatment can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1 month post-procedure. The primary efficacy endpoint is the technical success of the ClearLumen II Peripheral Thrombectomy System, defined as removal of ≥90% acute clot as documented by angiography. The primary safety endpoint is defined as the absence of device-related complications, which is defined as embolization, perforation or dissection caused by the ClearLumen II Peripheral Thrombectomy System. Secondary endpoints include procedural success, percent clot removed by the ClearLumen II Peripheral Thrombectomy System, clinical success at 1 month follow-up visit, 30-day target lesion revascularization, 30-days serious adverse events and 30-days adverse events.

The objective of this clinical investigation is to evaluate, in a controlled setting, the safety and efficacy of the recanalization of acute and subacute thrombotic (up to 6 weeks) femoropopliteal occlusions with the ClearLumen II Peripheral Thrombectomy System. Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion. Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category) and resting ankle-brachial index (ABI). During the procedure, the occlusion needs first to be recanalized by conventional guidewire technique, since the ClearLumen II Peripheral Thrombectomy System is an over-the-wire system (0.035"). After assessment of the lesion by angiography via a common femoral artery approach (contralateral/ipsilateral) the occlusion is intraluminally crossed with the wire according to physician's discretion. Afterwards, the device is introduced and the catheter is activated. Then the catheter is slowly advances into the occlusion. Several passages of the occlusion may needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of \>30% persists additional endovascular treatment can be performed according to the physician's discretion. The regular follow-up is necessary to monitor the condition of the patient and the result of the procedure. Patients will be invited for a follow-up visit 1 month after the index procedure. The following data will be collected during this follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.