BIOLUX P-III SPAIN All-Comers Registry

Biotronik

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Passeo-18 Lux DCB

Study type: Observational

Funder types: Industry

Identifiers

NCT03052296

C1603

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).