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)
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|ClinicalTrials.gov Identifier: NCT03845543|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Luminor-14 Paclitaxel eluting balloon||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: Luminor-14 paclitaxel eluting balloon
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Device: Luminor-14 Paclitaxel eluting balloon
Patients will be treated with the Luminor-14 paclitaxel eluting balloon
- Primary Efficacy Endpoint: Freedom from MALE [ Time Frame: 6 months post-procedure ]Freedom from major adverse limb events (MALE) defined as absence of above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision or thrombectomy/thrombolysis).
- Primary Safety Endpoint: Freedom from MALE [ Time Frame: 30 days post-procedure ]freedom from major adverse limb events defined as absence of above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision or thrombectomy/thrombolysis).
- Primary Safety Endpoint: Freedom from POD [ Time Frame: 30 days post-procedure ]No peri-operative death (POD) related to device, procedure or any other cause.
- Target Vessel Functional Flow Assessment [ Time Frame: 6 and 12 months post-procedure ]Target vessel functional flow assessment defined as the presence of blood flow using duplex ultrasound. Evidence of no blood flow within the treated segment indicates loss of patency.
- Freedom from clinically driven target vessel revascularisation [ Time Frame: 6 and 12 months post-procedure ]Freedom from clinical driven target lesion revascularization defined as absence of any reintervention due to clinical deterioration, defined as a worsening of the patient's quality of life, reflected by the health-questionnaire (EQ-5D), worsening of the Rutherford category with minimal 1 class or worsening of wound status.
- Amputation free survival [ Time Frame: 6 and 12 months post-procedure ]Amputation free survival defined as alive with freedom from any above the ankle target limb amputation
- Limb salvage [ Time Frame: 6 and 12 months post-procedure ]Limb salvage is defined as freedom from any above the ankle target limb amputation
- Procedural success [ Time Frame: During index procedure ]Procedural success is defined as restoration of at least 1 below the knee artery with <30% residual stenosis in the final angiogram and outflow into the foot.
- Wound healing status [ Time Frame: 1, 6 and 12 months post-procedure ]
Wound healing status is based on three parameters: the wound's diameter, the wound's depth and the % granulation tissue. These three parameters will be aggregated to one reported value using the modified Strauss wound classification scoring system.
Score 2: >75% red granulation tissue / <1cm² wound size / wound depth to the skin or subcutaneous.
Score 1: 50-75% red granulation tissue / 1-9cm² wound size / wound depth to muscle or tendon.
Score 0: <50% red granulation tissue / >9cm² wound size / wound depth to the bone or joint
- Wound healing time [ Time Frame: 1, 6 and 12 months post-procedure ]Wound healing time is defined as the number of days needed for the wound to heal completely after the index procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845543
|Contact: Koen Deloose, MD||+32(0) 52 25 25 email@example.com|
|Contact: Merel Verschueren, MSc||+32 (0) 52 25 27 firstname.lastname@example.org|
|OLV Ziekenhuis Aalst|
|Aalst, Oost-Vlaanderen, Belgium, 9300|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|Genk, Belgium, 3600|
|Milano, Milaan, Italy, 20099|
|Policlinico Abano Terme|
|Abano Terme, Padua, Italy, 1-35031|
|Contact: Marco Manzi, MD + 39 049 211 8221 email@example.com|
|Study Director:||Koen Deloose, MD||ID3 Medical|