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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
Condition: Peripheral Arterial Disease · Sponsor: ID3 Medical
About this study
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.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (9)
| OLV Ziekenhuis Aalst | Aalst, Oost-Vlaanderen, Belgium | — |
| Imelda Hospital | Bonheiden, Belgium | — |
| A.Z. Sint-Blasius | Dendermonde, Belgium | — |
| Z.O.L. | Genk, Belgium | — |
| AZ Groeninge | Kortrijk, Belgium | — |
| Regionaal Ziekenhuis Heilig Hart | Tienen, Belgium | — |
| Policlinico Abano Terme | Abano Terme, Padua, Italy | — |
| IRCCS Policlinico San Donato | San Donato, Italy | — |
| Hospital Univ. Germans Trias I Pujol | Badalona, Spain | — |
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Source record: clinicaltrials.gov/study/NCT03845543