BIOLUX P-III SPAIN All-Comers Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-22

Study Completion Date

2019-11-05

Brief Summary

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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

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Passeo-18 Lux DCB

The endovascular procedure is conducted as per the local standard practice and device instruction for use

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No