BIOLUX P-III BENELUX 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

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-24

Study Completion Date

2021-04-27

Brief Summary

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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

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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 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)

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No