Retrospective Follow-up of BIOLUX P-I/-II

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

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-25

Study Completion Date

2021-07-05

Brief Summary

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The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.

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Detailed Description

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Conditions

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Overall Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Passeo 18 PTA

Previous treatment with uncoated Passeo 18 PTA balloon catheter

Passeo-18

Intervention Type DEVICE

POBA

Passeo-18 Lux DCB

Previous teatment with Passeo-18 Lux DCB

Passeo-18 Lux

Intervention Type DEVICE

DCB

Interventions

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Passeo-18

POBA

Intervention Type DEVICE

Passeo-18 Lux

DCB

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II
2. Subject was treated either with Passeo-18 PTA or Passeo-18 LUX
3. Written informed consent by subject or subject's legal representative or impartial witness/waiver

Exclusion Criteria

1. Subject did neither participate in BIOLUX P-I nor BIOLUX P-II
2. Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA
3. Subject is not willing to sign an informed consent /data release form

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No