Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular — BIBLIOS  

Peripheral Arterial Disease Clinical Trial

Official title: Belgian-Italian Prospective, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of BTK Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular of 150 Subjects With Critical Limb Ischemia

Status Completed

Clinical Trial Summary

The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter of iVascular. An expected total of 150 patients will be treated. Infrapopliteal lesions will be treated during this trial. The Paclitaxel eluting balloon Luminor-14 is designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoint is defined as freedom from major adverse limb events, defined as above the ankle target limb amputations or major reintervention to the target lesions at 6 months. The primary safety endpoint is freedom from major adverse limb event at 30 days. The secondary endpoints consist of functional flow in target vessel, freedom from clinically driven target lesion revascularisation, above the ankle amputation free survival and limb salvage at 6 and 12 months, and also procedural success, wound healing status and wound healing time.

Clinical Trial Description

The objective of this clinical investigation is to assess the safety and efficacy of the Luminor-14 DCB for the treatment of infrapopliteal lesions patients with critical limb ischemia.

The 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 be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The 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 will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI), life quality and if applicable a wound assessment.

During the procedure the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. A pre-dilatation with a standard non-drug-coated balloon will be performed followed by a dilatation of the lesion with a Luminor-14 balloon (iVascular). If dilatation was not successful (>30% stenosis, perforation, occlusive or flow limiting dissection) prolonged inflation should be attempted after which bail-out stenting with a non-drug-coated dedicated BTK stent is allowed in case of inadequate results.

The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. Patients will be invited on weekly follow-up, with special attention to wound healing status at each visit until the wound is completely healed. The other required follow-up visits are 1,6 and 12 months follow-ups. During these visit the following data will be collected: medication record, physical exam, wound assessment and healing status, quality of life, duplex ultrasound of target vessel and possible adverse events. ;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT03845543
• Study type: Interventional
• Source: ID3 Medical
• Status: Completed
• Phase: N/A
• Start date: November 28, 2018
• Completion date: January 26, 2023