BIOLUX P-III SPAIN All-Comers Registry

B

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).

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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