NCT04250909

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

February 25, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

January 30, 2020

Last Update Submit

August 4, 2021

Conditions

Overall Mortality

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival at five years after index procedure, defined as death from any cause

    60 months

Secondary Outcomes (4)

  • Overall survival, defined as the time in days after index procedure to date of death from any cause.

    60 months

  • Major amputations of target extremities

    60 months

  • Clinically-driven target lesion revascularization

    60 months

  • Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.

    60 months

Study Arms (2)

Passeo 18 PTA

Previous treatment with uncoated Passeo 18 PTA balloon catheter

Device: Passeo-18

Passeo-18 Lux DCB

Previous teatment with Passeo-18 Lux DCB

Device: Passeo-18 Lux

Interventions

Passeo-18DEVICE

POBA

Passeo 18 PTA
Passeo-18 LuxDEVICE

DCB

Passeo-18 Lux DCB

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from previous studies.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

LKH Univ.-Klinikum Graz, Ambulanz für Angiologie

Graz, Austria

Location

Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie

Vienna, Austria

Location

Vascular Research Center Bornheiden, Imelda Hospital

Bonheiden, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, Belgium

Location

Clinic of Cardiology and Angiology II Bad Krozingen

Bad Krozingen, Germany

Location

Gefäßzentrum am KEH

Berlin, Germany

Location

University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)

Leipzig, Germany

Location

Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum

Rosenheim, Germany

Location

Study Officials

  • Thomas Zeller, Prof Dr

    Clinic of Cardiology and Angiology II Bad Krozingen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

February 25, 2020

Primary Completion

June 5, 2021

Study Completion

July 5, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations

AU(2)DE(4)BE(2)