Peripheral Arterial DiseaseNCT03052309
BIOLUX P-III BENELUX All-Comers Registry
An observational study of Peripheral Arterial Disease, run by Biotronik AG at 9 sites in 3 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Passeo-18 Lux DCB
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 24 Feb 2017to 27 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Belgium5 sites
Ziekenhuis Oost Limburg Genk
Genk
University Hospital Gent (UZ Gent)
Ghent
Algemeen Ziekenhuis Groeninge Kortrijk
Kortrijk
Algemeen Ziekenhuis Delta Roeselare
Roeselare
AZ Portaels
Vilvoorde
Netherlands3 sites
OLVG
Amsterdam
Maasstad Ziekenhuis
Rotterdam
Maxima Medisch Centrum Veldhoven
Veldhoven
About this study
Official title: BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX
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
- Conditions
- Peripheral Arterial Disease
- Being tested
- Passeo-18 Lux DCB
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passeo-18 Lux DCBDevice
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Major Adverse Events (MAE)
Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)
Measured: 6 months
Freedom from clinically driven target lesion revascularization (cd-TLR)
Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)
Measured: 12 months
Secondary outcomes (12)
Freedom from clinically-driven target lesion revascularization (cd-TLR)
Measured: 6 and 24 months
Freedom from clinically-driven target vessel revascularization (TVR)
Measured: 6, 12 and 24 months
Primary patency
freedom from >50% restenosis in the target lesion as indicated by a duplex ultrasound peak systolic velocity ratio (PSVR) >2.5 or by visual assessment of an angiogram with no clinically driven re-intervention
Measured: 12 and 24 months
Freedom from Major Adverse Events (MAE)
Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)
Measured: 12 and 24 months
Change in mean Ankle Brachial Index (ABI)
compared to the pre-procedure
Measured: 6, 12 and 24 months
Improvement in Rutherford classification
compared to the pre-procedure Rutherford classification
Measured: 6, 12 and 24 months
Amputation-free survival (AFS)
including major, minor and overall AFS
Measured: 6, 12 and 24 months
Pain score
compared to the pre-procedure score.
Measured: 6, 12 and 24 months
Walking Impairment Questionnaire
compared to the pre-procedure score.
Measured: 6, 12 and 24 months
Device success
Successful delivery, inflation, deflation, and retrieval of the Passeo-18 Lux DCB
Measured: immediately upon index procedure
Technical success
Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation
Measured: immediately upon index procedure
Procedural success
Procedural success is technical and device success without the occurrence of any MAE (as defined in the protocol) during the hospital stay
Measured: immediately upon discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start24 Feb 2017
- Primary completion9 Jun 2020
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franck Vermassen, Principal investigator, UZ GentJGAM Blomjous, Principal investigator, OLVG Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052309
- Sponsor's protocol ID
- C1604
- Status last verified
- Aug 2022
- First submitted
- 2 Feb 2017
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - A Prospective, International, Multi-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Popliteal Arteries - III BENELUX
- ClinicalTrials.gov ID
- NCT03052309
- Acronym / sponsor ID
- C1604
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 14 Feb 2017 (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 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The BIOLUX P-III BENELUX registry will include subjects from an all-comers patient population with all subjects requiring popliteal artery revascularization with the Passeo-18 Lux DCB
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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-18 Lux DCBThe 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) | Device | – |
Primary outcome
Freedom from Major Adverse Events (MAE)
Time frame: 6 months
Freedom from Major Adverse Events (MAE): A composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven target lesion revascularization (TLR)
Freedom from clinically driven target lesion revascularization (cd-TLR)
Time frame: 12 months
Any re-intervention performed for ≥ 50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.)
12 secondary outcomes
Freedom from clinically-driven target lesion revascularization (cd-TLR)
Time frame: 6 and 24 months
Freedom from clinically-driven target vessel revascularization (TVR)
Time frame: 6, 12 and 24 months
Primary patency
Time frame: 12 and 24 months
Freedom from Major Adverse Events (MAE)
Time frame: 12 and 24 months
Change in mean Ankle Brachial Index (ABI)
Time frame: 6, 12 and 24 months
Improvement in Rutherford classification
Time frame: 6, 12 and 24 months
Amputation-free survival (AFS)
Time frame: 6, 12 and 24 months
Pain score
Time frame: 6, 12 and 24 months
Walking Impairment Questionnaire
Time frame: 6, 12 and 24 months
Device success
Time frame: immediately upon index procedure
Technical success
Time frame: immediately upon index procedure
Procedural success
Time frame: immediately upon discharge
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 15 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Franck Vermassen principal investigator
UZ Gent
JGAM Blomjous principal investigator
OLVG Amsterdam
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Biotronik AG at 9 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 8 inclusion and 8 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Netherlands, Luxembourg. 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?
Freedom from Major Adverse Events (MAE) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 15 Aug 2022.