AtherosclerosisBIOLUX P-IINCT01867736
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries
A study testing Passeo-18 Lux DRB and Standard PTA (POBA) in people with Atherosclerosis and Arteriosclerosis, run by Biotronik AG at 6 sites in 3 countries.
Trial summary
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Arteriosclerosis, Vascular Disease
- What is being tested?
- Passeo-18 Lux DRB and Standard PTA (POBA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jul 2012to Jul 2014
- Phase
- Interventional
- 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
Who may be able to join
- Subject has provided written informed consent.
- Subject is willing and able to comply with follow-up evaluations.
- Subject is ≥ 18 years old.
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
- A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
- Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
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- Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
- Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
- At least one non-occluded crural vessel with angiographically documented run-off to the foot.
- Successful wire crossing of the lesion.
Who cannot join
- Flow-limiting (> 50% DS) inflow lesion proximal to target lesion, left untreated.
- Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
- Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
- Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
- Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
- Previous bypass surgery of target vessel.
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- Previously implanted stent in target lesion.
- Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
- Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
- Subject with acute MI ≤ 3 months.
- Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
- Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
- Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
- Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
- Co- morbid conditions limiting life expectancy ≤ 1 year.
- Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
- Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Universitäts-Herzzentrum Freiburg
Bad Krozingen
Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin
Parkkrankenhaus Leipzig Südost GmbH
Leipzig
About this study
Official title: BIOTRONIK's - First in Men Study of the Passeo-18 LUX Drug Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Subjects Requiring Revascularization of Infrapopliteal Arteries (BIOLUX P-II).
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.
- Being tested
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Keywords
- Stenosis, Occlusions, Infrapopliteal arteries, Below the knee arteries, PTA, POBA, DRB
- Medical subject headings
- Atherosclerosis, Arteriosclerosis, Vascular Diseases, Peripheral Arterial Disease, Constriction, Pathologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passeo-18 Lux DRBDevice
Also called Passeo-18 LUX Drug Releasing PTA Balloon Catheter
Standard PTA (POBA)Device
Also called Uncoated Passeo-18 PTA balloon catheter
| Study group | Role | What they receive |
|---|---|---|
| Passeo-18 Lux DRB | Experimental | Passeo-18 Lux Drug Releasing Balloon catheter Receives: Device: Passeo-18 Lux DRB |
| Standard PTA (POBA) | Active comparator | Uncoated Passeo-18 PTA balloon catheter Receives: Device: Standard PTA (POBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days.
Measured: 30 days
Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA).
Measured: 6 months
Secondary outcomes (12)
Target lesion failure, assessed by target lesion revascularization (TLR) rate at 6 months and 12 months
Measured: 6 and 12 months
Target vessel revascularization (TVR) rate at 6 months and 12 months
Measured: 6 and 12 months
Binary re-stenosis rate at 6 months, assessed by QVA
Measured: 6 months
Major adverse event rate, defined as all cause death, major amputation of target extremity, target lesion thrombosis, TLR and TVR at 6 months and 12 months
Measured: 6 and 12 months
Change in mean ABI at discharge, 30 days, 6 months and 12 months
Measured: Discharge, 30 days, 6 months and 12 months
Change in Rutherford classification at 30 days, 6 months and 12 months
Measured: 30 days, 6 months and 12 months
Quality of life evaluation, assessed by EQ5D questionnaire at baseline, 30 days, 6 months and 12 months
Measured: Baseline, 30 days, 6 months and 12 months
Duplex based primary patency at 30 days, 6 months and 12 months
Measured: 30 days, 6 months and 12 months
Procedural success, defined as successful vascular access, completion of endovascular procedure and immediate morphologic success with a residual stenosis <30%.
Measured: Day 0
Device success, defined as exact deployment according to Instructions For Use
Measured: Day 0
Technical success, defined as device or procedural success without the occurrence of major adverse events during the hospital stay.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Late Lumen Loss
Measured: 6-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, MD, Principal investigator, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867736
- Sponsor's protocol ID
- C1102
- Acronym
- BIOLUX P-II
- Status last verified
- Feb 2015
- First submitted
- 27 May 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK's - First in Men Study of the Passeo-18 LUX Drug Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Subjects Requiring Revascularization of Infrapopliteal Arteries (BIOLUX P-II).
- ClinicalTrials.gov ID
- NCT01867736
- Acronym / sponsor ID
- BIOLUX P-II / C1102
- Keywords
- Stenosis, Occlusions, Infrapopliteal arteries, Below the knee arteries, PTA, POBA, DRB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- 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.
A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passeo-18 Lux DRB | Experimental | Device: Passeo-18 Lux DRBPasseo-18 Lux Drug Releasing Balloon catheter |
| Standard PTA (POBA) | Active comparator | Device: Standard PTA (POBA)Uncoated Passeo-18 PTA balloon catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has provided written informed consent.
- Subject is willing and able to comply with follow-up evaluations.
- Subject is ≥ 18 years old.
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
- A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
Key exclusion criteria (18 listed)
- Flow-limiting (> 50% DS) inflow lesion proximal to target lesion, left untreated.
- Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion (DEB or DES not allowed for the treatment of inflow lesions).
- Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
- Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
- Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
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 DRBAlso: Passeo-18 LUX Drug Releasing PTA Balloon Catheter | Device | Passeo-18 Lux DRB |
| Standard PTA (POBA)Also: Uncoated Passeo-18 PTA balloon catheter | Device | Standard PTA (POBA) |
Primary outcome
Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days.
Time frame: 30 days
Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA).
Time frame: 6 months
12 secondary outcomes
Target lesion failure, assessed by target lesion revascularization (TLR) rate at 6 months and 12 months
Time frame: 6 and 12 months
Target vessel revascularization (TVR) rate at 6 months and 12 months
Time frame: 6 and 12 months
Binary re-stenosis rate at 6 months, assessed by QVA
Time frame: 6 months
Major adverse event rate, defined as all cause death, major amputation of target extremity, target lesion thrombosis, TLR and TVR at 6 months and 12 months
Time frame: 6 and 12 months
Change in mean ABI at discharge, 30 days, 6 months and 12 months
Time frame: Discharge, 30 days, 6 months and 12 months
Change in Rutherford classification at 30 days, 6 months and 12 months
Time frame: 30 days, 6 months and 12 months
Quality of life evaluation, assessed by EQ5D questionnaire at baseline, 30 days, 6 months and 12 months
Time frame: Baseline, 30 days, 6 months and 12 months
Duplex based primary patency at 30 days, 6 months and 12 months
Time frame: 30 days, 6 months and 12 months
Procedural success, defined as successful vascular access, completion of endovascular procedure and immediate morphologic success with a residual stenosis <30%.
Time frame: Day 0
Device success, defined as exact deployment according to Instructions For Use
Time frame: Day 0
Technical success, defined as device or procedural success without the occurrence of major adverse events during the hospital stay.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1-2 days
Late Lumen Loss
Time frame: 6-months post-procedure
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 9 Feb 2015.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
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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, MD principal investigator
Universitäts-Herzzentrum Freiburg - Bad Krozingen, Germany
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passeo-18 Lux DRB and Standard PTA (POBA) in people with Atherosclerosis and Arteriosclerosis, run by Biotronik AG at 6 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 10 inclusion and 18 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Austria. 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?
Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days. (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT01867736, which also lists 1 linked publication.
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 9 Feb 2015; AzTrials last refreshed its copy on 1 Nov 2026.