Clinical trial NCT03052309: BIOLUX P-III BENELUX All-Comers Registry
Official title: BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB

Brief summary: The purpose of the BIOLUX P-III BENELUX Registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries


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
* Lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the Passeo-18 Lux drug coated balloon.
* Isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery
* Inflow free from flow-limiting lesion. Patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment
* At least one native artery with direct outflow artery to the foot
* Rutherford classification 2-5
* Patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Rutherford classification 6
* Lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk)
* Aneurysm at the level of the popliteal artery
* 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)
* 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

Primary outcomes:
measure: Freedom from Major Adverse Events (MAE)
timeFrame: 6 months
measure: Freedom from clinically driven target lesion revascularization (cd-TLR)
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from clinically-driven target lesion revascularization (cd-TLR)
timeFrame: 6 and 24 months
measure: Freedom from clinically-driven target vessel revascularization (TVR)
timeFrame: 6, 12 and 24 months
measure: Primary patency
timeFrame: 12 and 24 months
measure: Freedom from Major Adverse Events (MAE)
timeFrame: 12 and 24 months
measure: Change in mean Ankle Brachial Index (ABI)
timeFrame: 6, 12 and 24 months
measure: Improvement in Rutherford classification
timeFrame: 6, 12 and 24 months
measure: Amputation-free survival (AFS)
timeFrame: 6, 12 and 24 months
measure: Pain score
timeFrame: 6, 12 and 24 months
measure: Walking Impairment Questionnaire
timeFrame: 6, 12 and 24 months
measure: Device success
timeFrame: immediately upon index procedure
measure: Technical success
timeFrame: immediately upon index procedure
measure: Procedural success
timeFrame: immediately upon discharge
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg Genk
city: Gent
country: Belgium
facility: University Hospital Gent (UZ Gent)
city: Kortrijk
country: Belgium
facility: Algemeen Ziekenhuis Groeninge Kortrijk
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta Roeselare
city: Vilvoorde
country: Belgium
facility: AZ Portaels
city: Luxembourg
country: Luxembourg
facility: Centre Hospitaliers Luxembourg
city: Amsterdam
country: Netherlands
facility: OLVG
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum Veldhoven
Study officials:
affiliation: UZ Gent
name: Franck Vermassen
role: PRINCIPAL_INVESTIGATOR
affiliation: OLVG Amsterdam
name: JGAM Blomjous
role: PRINCIPAL_INVESTIGATOR
References: