BIOLUX P-III BENELUX All-Comers Registry

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT03052309
• Lead Sponsor: Biotronik AG

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2017-02-24
• Primary Completion: 2020-06-09
• Study Completion: 2021-04-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Events (MAE)	6 months	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)
Freedom from clinically driven target lesion revascularization (cd-TLR)	12 months	Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)

Secondary Outcome Measures

Name	Time	Method
Freedom from clinically-driven target vessel revascularization (TVR)	6, 12 and 24 months
Change in mean Ankle Brachial Index (ABI)	6, 12 and 24 months	compared to the pre-procedure
Device success	immediately upon index procedure	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB
Technical success	immediately upon index procedure	Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
Freedom from Major Adverse Events (MAE)	12 and 24 months	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)
Walking Impairment Questionnaire	6, 12 and 24 months	compared to the pre-procedure score.
Primary patency	12 and 24 months	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
Improvement in Rutherford classification	6, 12 and 24 months	compared to the pre-procedure Rutherford classification
Amputation-free survival (AFS)	6, 12 and 24 months	including major, minor and overall AFS
Freedom from clinically-driven target lesion revascularization (cd-TLR)	6 and 24 months
Pain score	6, 12 and 24 months	compared to the pre-procedure score.
Procedural success	immediately upon discharge	Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay

Trial Locations

Locations (9)

Algemeen Ziekenhuis Groeninge Kortrijk; 🇧🇪 Kortrijk, Belgium

OLVG; 🇳🇱 Amsterdam, Netherlands

Maxima Medisch Centrum Veldhoven; 🇳🇱 Veldhoven, Netherlands

University Hospital Gent (UZ Gent); 🇧🇪 Gent, Belgium

Centre Hospitaliers Luxembourg; 🇱🇺 Luxembourg, Luxembourg

AZ Portaels; 🇧🇪 Vilvoorde, Belgium

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Ziekenhuis Oost Limburg Genk; 🇧🇪 Genk, Belgium

Algemeen Ziekenhuis Delta Roeselare; 🇧🇪 Roeselare, Belgium