BIOLUX P-III BENELUX All-Comers Registry

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052309
• Other study ID #: C1604
• Status: Completed
• Start date: February 24, 2017
• Est. completion date: April 27, 2021

Study information

• Verified date: August 2022
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 27, 2021
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Passeo-18 Lux DCB
The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Belgium,  Luxembourg,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Freedom from clinically-driven target lesion revascularization (cd-TLR)		6 and 24 months
Secondary	Freedom from clinically-driven target vessel revascularization (TVR)		6, 12 and 24 months
Secondary	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
Secondary	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
Secondary	Change in mean Ankle Brachial Index (ABI)	compared to the pre-procedure	6, 12 and 24 months
Secondary	Improvement in Rutherford classification	compared to the pre-procedure Rutherford classification	6, 12 and 24 months
Secondary	Amputation-free survival (AFS)	including major, minor and overall AFS	6, 12 and 24 months
Secondary	Pain score	compared to the pre-procedure score.	6, 12 and 24 months
Secondary	Walking Impairment Questionnaire	compared to the pre-procedure score.	6, 12 and 24 months
Secondary	Device success	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB	immediately upon index procedure
Secondary	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
Secondary	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