Clinical trial NCT03052296: BIOLUX P-III SPAIN All-Comers Registry
Official title: BIOTRONIK - A Prospective, National, Multi-centre, Post-market Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Long Femoropopliteal Artery Lesions - III SPAIN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The BIOLUX P-III SPAIN registry will include subjects from an all-comers patient population with all subjects requiring revascularization of long femoropopliteal artery lesions with the Passeo-18 Lux DCB

Brief summary: The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
* Subject classified as Rutherford class 4, 5 or 6
* TASC C or D lesion(s) in the femoropopliteal artery
* Lesion length \> 15 cm suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
* Subject is pregnant or planning to become pregnant during the course of the study.
* Rutherford class \<4
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
* Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation).

Primary outcomes:
measure: Freedom from Major Adverse Events (MAE)
timeFrame: 6 months
measure: Freedom from clinically driven Target Lesion Revascularization (TLR)
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from clinically-driven target lesion revascularization (TLR)
timeFrame: 6 months
measure: Freedom from clinically-driven target vessel revascularization (TVR)
timeFrame: 6 and 12 months
measure: Primary Patency
timeFrame: 12 months
measure: Freedom from MAE
timeFrame: 12 months
measure: Change in mean Ankle Brachial Index (ABI)
timeFrame: 6 and 12 months
measure: Improvement in Rutherford classification compared to the pre-procedure Rutherford classification
timeFrame: 6 and 12 months
measure: Amputation-free survival (AFS) including major, minor and overall AFS
timeFrame: 6 and 12 months
measure: Pain score compared to the pre-procedure score
timeFrame: 6 and 12 months
measure: Walking Impairment Questionnaire compared to the pre-procedure score
timeFrame: 6 and 12 months
measure: Device success
timeFrame: Immediately upon procedure
measure: Technical success
timeFrame: Immediately upon procedure
measure: Procedural success
timeFrame: Immediately upon discharge
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Mataró
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa Zaragoza
Study officials:
affiliation: Hospital Clínico and University of Zaragoza
name: Miguel Angel de Gregorio
role: PRINCIPAL_INVESTIGATOR
References: