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

NCT03845543 | Completed Results

• 1 other identifier: BIBLIOS-Luminor14BTK
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 9

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  30 days post-procedure

• Primary Safety Endpoint: Freedom From POD

  No peri-operative death (POD) related to device, procedure or any other cause.

  30 days post-procedure

Secondary Outcomes (7)

• Target Vessel Functional Flow Assessment

  6 and 12 months post-procedure

• Freedom From Clinically Driven Target Vessel Revascularisation

  6 and 12 months post-procedure

• Amputation Free Survival

  6 and 12 months post-procedure

• Limb Salvage

  6 and 12 months post-procedure

• Procedural Success

  During index procedure

Study Arms (1)

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).

Device: Luminor-14 Paclitaxel eluting balloon

Interventions

Luminor-14 Paclitaxel eluting balloon DEVICE

Patients will be treated with the Luminor-14 paclitaxel eluting balloon

Luminor-14 paclitaxel eluting balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (9)

OLV Ziekenhuis Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

Z.O.L.

Genk, 3600, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Regionaal Ziekenhuis Heilig Hart

Tienen, 3300, Belgium

Location

Policlinico Abano Terme

Abano Terme, Padua, 1-35031, Italy

Location

IRCCS Policlinico San Donato

San Donato, 20097, Italy

Location

Hospital Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Clinical Research Professional
• Organization: iD3 Medical

office@iD3medical.com

+32 (0)52252745

Study Officials

• Koen Deloose, MD

  ID3 Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 19, 2019
• Study Start: November 28, 2018
• Primary Completion: July 13, 2022
• Study Completion: January 26, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-11

Locations

BE (6); IT (2); ES (1)