BIOLUX P-III BENELUX All-Comers Registry

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Passeo-18 Lux DCB

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium
    • Ziekenhuis Oost Limburg Genk
  • Gent, Belgium
    • University Hospital Gent (UZ Gent)
  • Kortrijk, Belgium
    • Algemeen Ziekenhuis Groeninge Kortrijk
  • Roeselare, Belgium
    • Algemeen Ziekenhuis Delta Roeselare
  • Vilvoorde, Belgium
    • AZ Portaels
• Luxembourg
  • Luxembourg, Luxembourg
    • Centre Hospitaliers Luxembourg
• Netherlands
  • Amsterdam, Netherlands
    • OLVG
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Veldhoven, Netherlands
    • Maxima Medisch Centrum Veldhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Major Adverse Events (MAE)	Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)	6 months
Freedom from clinically driven target lesion revascularization (cd-TLR)	Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically-driven target lesion revascularization (cd-TLR)		6 and 24 months
Freedom from clinically-driven target vessel revascularization (TVR)		6, 12 and 24 months
Primary patency	freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) >2.5 or by visual assessment of an angiogram with no clinically driven re-intervention	12 and 24 months
Freedom from Major Adverse Events (MAE)	Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)	12 and 24 months
Change in mean Ankle Brachial Index (ABI)	compared to the pre-procedure	6, 12 and 24 months
Improvement in Rutherford classification	compared to the pre-procedure Rutherford classification	6, 12 and 24 months
Amputation-free survival (AFS)	including major, minor and overall AFS	6, 12 and 24 months
Pain score	compared to the pre-procedure score.	6, 12 and 24 months
Walking Impairment Questionnaire	compared to the pre-procedure score.	6, 12 and 24 months
Device success	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB	immediately upon index procedure
Technical success	Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation	immediately upon index procedure
Procedural success	Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay	immediately upon discharge

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: Franck Vermassen, UZ Gent; Principal Investigator: JGAM Blomjous, OLVG Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: C1604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No