Peripheral Arterial DiseaseBIBLIOSNCT03845543
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
A study testing Luminor-14 Paclitaxel eluting balloon in people with Peripheral Arterial Disease, run by ID3 Medical at 9 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Luminor-14 Paclitaxel eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 28 Nov 2018to 26 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant females ≥ 18 years of age at the time of consent. Females of childbearing potential have a negative pregnancy test <7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female participants will be exempted from this requirement in case they are sterile, infertile or have been post-menopausal for at least 12 months
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the informed consent form. An impartial witness may sign on behalf of the subject.
- Willing to comply with all required follow-up visits
- Rutherford Classification 5
- Significant degree of stenosis >70% or chronic total occlusion (CTO)
- Infrapopliteal lesion: P3 to the ankle-joint level (not below-the-ankle (BTA)); full length lesions or tandem lesions are allowed
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- Wound, Ischemia, foot Infection (WIfI) tissue loss grade 1-2 at baseline
- WIfI foot infection grade of 0-2 at baseline
- WIfI ischemia grade 2-3 at baseline
- Estimated life expectancy ≥ 1 year
- Multiple lesions can be treated if they are located in separate vessels per standard of care but only one (1) BTK vessel can be considered as the target lesion/vessel and need to be treated according the Clinical Investigation Protocol (CIP) guidelines.
- Target vessel should give direct or indirect run-off to the foot (clearly documented in a foot/BTA angiogram)
- Patients with in-flow lesions can be included if the lesions are treated successfully (residual stenosis ≤30%) with the same drug coated balloon (DCB) platform, bail-out stenting with a bare-metal stent (BMS).
- Successful pre-dilatation of the target lesion (≤30% residual stenosis)
Who cannot join
- Previous bypass graft in the target limb
- Acute limb ischemia, defined as symptom onset during less than 14 days prior to the index procedure
- Prior or planned above-the-ankle amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridement)
- Previous DCB treatment in target vessel 6 months prior to index procedure
- WIfI tissue loss grade 0 or 3 at baseline
- WIfI foot infection grade 3 at baseline
Show all 24Show fewer
- WIfI ischemia grade 0-1 at baseline
- Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12.000/or febrile state or C reactive protein (CRP)>5mg/L
- Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb within 30 days after the index procedure
- Existing stent implant in the target vessel
- Use of alternative therapies: atherectomy, cutting/scoring balloons, laser, …
- Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80.000/μL or greater than 500.000/μL
- Any subject in which antiplatelet, anticoagulant or thrombolytic therapy is contraindicated
- Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the index procedure
- History of stroke or transient ischemic attack (TIA) less than 90 days prior to the index procedure
- Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
- Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up
- Patients on haemodialysis
- Known hypersensitivity or allergy to contrast agents that cannot be medically managed
- Known hypersensitivity or allergy to heparin, aspirin, paclitaxel, clopidogrel or other antiplatelet/anticoagulant therapies
- Inadequate inflow lesion treatment (>30% residual stenosis)
- Inadequate result of pre-dilatation (>30% residual stenosis)
- Inadequate run-off to the foot
- Bilateral BTK enrolment in this study
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Belgium6 sites
OLV Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, 9300
Imelda Hospital
Bonheiden, 2820
A.Z. Sint-Blasius
Dendermonde, 9200
Z.O.L.
Genk, 3600
AZ Groeninge
Kortrijk, 8500
Regionaal Ziekenhuis Heilig Hart
Tienen, 3300
Italy2 sites
Policlinico Abano Terme
Abano Terme, Padua, 1-35031
IRCCS Policlinico San Donato
San Donato, 20097
About this study
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
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.
Read the 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 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Luminor-14 Paclitaxel eluting balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminor-14 Paclitaxel eluting balloonDevice
Patients will be treated with the Luminor-14 paclitaxel eluting balloon
| Study group | Role | What they receive |
|---|---|---|
| Luminor-14 paclitaxel eluting balloon | Experimental | 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). Receives: Device: Luminor-14 Paclitaxel eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Freedom From MALE
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).
Measured: 6 months post-procedure
Primary Safety Endpoint: Freedom From MALE
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).
Measured: 30 days post-procedure
Primary Safety Endpoint: Freedom From POD
No peri-operative death (POD) related to device, procedure or any other cause.
Measured: 30 days post-procedure
Secondary outcomes (7)
Target Vessel Functional Flow Assessment
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.
Measured: 6 and 12 months post-procedure
Freedom From Clinically Driven Target Vessel Revascularisation
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.
Measured: 6 and 12 months post-procedure
Amputation Free Survival
Amputation free survival defined as alive with freedom from any above the ankle target limb amputation
Measured: 6 and 12 months post-procedure
Limb Salvage
Limb salvage is defined as freedom from any above the ankle target limb amputation
Measured: 6 and 12 months post-procedure
Procedural Success
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.
Measured: During index procedure
Mean Wound Healing Status
At 1, 6 and 12 months visits, the healing status of each wound will be scored based on 3 parameters:
Wound's diameter: 0 points for wounds with diameter >9cm², 1 point for wounds with diameter 1-9cm², 2 points for wounds with diameter <1cm² Wound's depth: 0 points for depth to the bone/joint wounds, 1 point depth to muscle/tendon wounds, 2 points depth to the skin or subcutaneous wounds
% granulation tissue: 0 points for a wound with <50% red granulation tissue, 1 point for a wound with 50-75% red granulation tissue, 2 points for a wound with >75% red granulation tissue A total wound healing score is calculated by combining the 3 parameter points. E.g.:wound with diameter 1-9cm², depth to the bone, and <50% red granulation tissue has a score of 1+0+0=1. A wound with a score 6/6 is the best possible score for a non-healed wound while a 0/6 is the worst score a wound can have.
After all total wound healing scores are calculated, a mean for each follow-up visit is calculated.
Measured: 1, 6 and 12 months post-procedure
Wound Healing Time
Wound healing time is defined as the number of days needed for the wound to heal completely after the index procedure.
Measured: 1, 6 and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start28 Nov 2018
- Primary completion13 Jul 2022
- Study completion26 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Study director, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845543
- Sponsor's protocol ID
- BIBLIOS-Luminor14BTK
- Acronym
- BIBLIOS
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2019
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03845543
- Acronym / sponsor ID
- BIBLIOS / BIBLIOS-Luminor14BTK
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 26 Jan 2023 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luminor-14 paclitaxel eluting balloon | Experimental | Device: Luminor-14 Paclitaxel eluting balloonPre-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males or non-pregnant females ≥ 18 years of age at the time of consent. Females of childbearing potential have a negative pregnancy test <7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female participants will be exempted from this requirement in case they are sterile, infertile or have been post-menopausal for at least 12 months
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the informed consent form. An impartial witness may sign on behalf of the subject.
- Willing to comply with all required follow-up visits
- Rutherford Classification 5
- Significant degree of stenosis >70% or chronic total occlusion (CTO)
Key exclusion criteria (24 listed)
- Previous bypass graft in the target limb
- Acute limb ischemia, defined as symptom onset during less than 14 days prior to the index procedure
- Prior or planned above-the-ankle amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridement)
- Previous DCB treatment in target vessel 6 months prior to index procedure
- WIfI tissue loss grade 0 or 3 at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luminor-14 Paclitaxel eluting balloonPatients will be treated with the Luminor-14 paclitaxel eluting balloon | Device | Luminor-14 paclitaxel eluting balloon |
Primary outcome
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.
7 secondary outcomes
Target Vessel Functional Flow Assessment
Time frame: 6 and 12 months post-procedure
Freedom From Clinically Driven Target Vessel Revascularisation
Time frame: 6 and 12 months post-procedure
Amputation Free Survival
Time frame: 6 and 12 months post-procedure
Limb Salvage
Time frame: 6 and 12 months post-procedure
Procedural Success
Time frame: During index procedure
Mean Wound Healing Status
Time frame: 1, 6 and 12 months post-procedure
Wound Healing Time
Time frame: 1, 6 and 12 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD study director
ID3 Medical
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminor-14 Paclitaxel eluting balloon in people with Peripheral Arterial Disease, run by ID3 Medical at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Freedom From MALE (time frame: 6 months post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.