BIOLUX P-III SPAIN All-Comers Registry

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052296
• Other study ID #: C1603
• Status: Completed
• Start date: March 22, 2017
• Est. completion date: November 5, 2019

Study information

• Verified date: August 2021
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• 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

• 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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Passeo-18 Lux DCB
The endovascular procedure is conducted as per the local standard practice and device instruction for use

Locations

Country	Name	City	State
Spain	Hospital Mataró	Barcelona
Spain	Hospital San Cecilio	Granada
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital Clínico Lozano Blesa Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (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 (TLR)		6 months
Secondary	Freedom from clinically-driven target vessel revascularization (TVR)		6 and 12 months
Secondary	Primary Patency	defined as 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 months
Secondary	Freedom from MAE	Composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR	12 months
Secondary	Change in mean Ankle Brachial Index (ABI)	Thigh or toe brachial index (TBI) may be used / performed if ABI is inadequate	6 and 12 months
Secondary	Improvement in Rutherford classification compared to the pre-procedure Rutherford classification		6 and 12 months
Secondary	Amputation-free survival (AFS) including major, minor and overall AFS		6 and 12 months
Secondary	Pain score compared to the pre-procedure score		6 and 12 months
Secondary	Walking Impairment Questionnaire compared to the pre-procedure score		6 and 12 months
Secondary	Device success	Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB.	Immediately upon 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 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