Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03845543
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2019-01-09
Brief Title:
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
Sponsor:
ID3 Medical
Organization:
ID3 Medical
Study Overview
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
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIBLIOS
Brief 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
Detailed 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 investigators assessment evaluation of the underlying disease and the eligibility criteria The patients 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 16 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
The patients will be selected based on the investigators assessment evaluation of the underlying disease and the eligibility criteria The patients 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 16 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None