Overall MortalityNCT04250909
Retrospective Follow-up of BIOLUX P-I/-II
An observational study of Overall Mortality, run by Biotronik AG at 8 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Overall Mortality
- What is being tested?
- Passeo-18 and Passeo-18 Lux
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 25 Feb 2020to 5 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from previous studies.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany4 sites
Clinic of Cardiology and Angiology II Bad Krozingen
Bad Krozingen
Gefäßzentrum am KEH
Berlin
University Leipzig Medical Centre Medizinische Klinik und Poliklinik V (Angiologie)
Leipzig
Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum
Rosenheim
Austria2 sites
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz
Allgemeines Krankenhaus - Universitätsklinik für Radiodiagnostik, Klinische Abteilung für Kardiovaskuläre und Interventionelle Radiologie
Vienna
Belgium2 sites
Vascular Research Center Bornheiden, Imelda Hospital
Bonheiden
A.Z. Sint-Blasius
Dendermonde
About this study
Official title: Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries
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.
- Conditions
- Overall Mortality
- Being tested
- Passeo-18, Passeo-18 Lux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passeo-18Device
POBA
Passeo-18 LuxDevice
DCB
| Study group | Role | What they receive |
|---|---|---|
| Passeo 18 PTA | Previous treatment with uncoated Passeo 18 PTA balloon catheter Receives: Device: Passeo-18 | |
| Passeo-18 Lux DCB | Previous teatment with Passeo-18 Lux DCB Receives: Device: Passeo-18 Lux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival at five years after index procedure, defined as death from any cause
Measured: 60 months
Secondary outcomes (4)
Overall survival, defined as the time in days after index procedure to date of death from any cause.
Measured: 60 months
Major amputations of target extremities
Measured: 60 months
Clinically-driven target lesion revascularization
Measured: 60 months
Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start25 Feb 2020
- Primary completion5 Jun 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof Dr, Study chair, Clinic of Cardiology and Angiology II Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250909
- Sponsor's protocol ID
- C1901
- Status last verified
- Aug 2021
- First submitted
- 30 Jan 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries
- ClinicalTrials.gov ID
- NCT04250909
- Acronym / sponsor ID
- C1901
- Conditions
- Overall Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passeo 18 PTA | – | Device: Passeo-18Previous treatment with uncoated Passeo 18 PTA balloon catheter |
| Passeo-18 Lux DCB | – | Device: Passeo-18 LuxPrevious teatment with Passeo-18 Lux DCB |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from previous studies.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passeo-18POBA | Device | Passeo 18 PTA |
| Passeo-18 LuxDCB | Device | Passeo-18 Lux DCB |
Primary outcome
Overall survival
Time frame: 60 months
Overall survival at five years after index procedure, defined as death from any cause
4 secondary outcomes
Overall survival, defined as the time in days after index procedure to date of death from any cause.
Time frame: 60 months
Major amputations of target extremities
Time frame: 60 months
Clinically-driven target lesion revascularization
Time frame: 60 months
Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II.
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zeller, Prof Dr study chair
Clinic of Cardiology and Angiology II Bad Krozingen
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overall Mortality, run by Biotronik AG at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.