AtherosclerosisNCT01221610
BIOLUX P-I First in Man Study
A study testing Passeo-18 Lux DRB and Standard PTA (POBA) in people with Atherosclerosis and Arteriosclerosis, run by Biotronik AG at 5 sites in 2 countries.
Trial summary
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 50 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
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2010to Jan 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years,
- Informed consent signed by patient prior to randomization
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
- Rutherford Class 2 - 5 in the target limb
- Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
- Inflow free from flow-limiting lesion (< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
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- At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
- Successful wire crossing of the lesion
- Willingness to comply with all specified follow-up evaluations
- Male or negative pregnancy test of women in childbearing age
Who cannot join
- Co-morbid conditions limiting life expectancy ≤ 1 year
- Patient currently participating in another clinical trial
- Lesions which are untreatable with PTA or other interventional techniques
- The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
- Thrombus in the target vessel, documented by angiography
- Target lesion is severely calcified, documented by angiography
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- Prior bypass surgery of target vessel
- Previously implanted stent in the target lesion
- Treatment of bifurcation required
- Planned amputation of the target limb
- 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 in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)
- Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 %
- Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy
- Phenprocoumon intake
- Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
- Known allergy to contrast media that cannot be adequately controlled with pre-medication
- Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen
Gefaesszentrum Berlin, Medizinische Klinik, Ev. Krankenhaus Königin Elisabeth Herzberge
Berlin
Parkkrankenhaus Leipzig Südost GmbH
Leipzig
Institut für diagnostische und interventionelle Radiologie, Klinikum Rosenheim
Rosenheim
Austria1 site
AKH Wien, Kardiovaskuläre und Interventionelle Radiologie
Vienna
About this study
Official title: A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).
A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.
- Being tested
- Passeo-18 Lux DRB, Standard PTA (POBA)
- Keywords
- Stenosis, Occlusions, SFA, 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 Balloon catheter
Standard PTA (POBA)Device
Also called Passeo-18 PTA catheter
| Study group | Role | What they receive |
|---|---|---|
| Drug Releasing Balloon | Experimental | Passeo-18 Lux Drug Releasing Balloon catheter Receives: Device: Passeo-18 Lux DRB |
| Standard PT A (POBA) | Active comparator | Uncoated Passeo-18 PTA catheter Receives: Device: Standard PTA (POBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
Measured: 6 months
Secondary outcomes (5)
6 months binary restenosis rate
Measured: 6 months
6 months and 12 months TLR rate
Measured: 6 and 12 months
6 months and 12 months change in mean ABI
Measured: 6 and 12 months
6 months and 12 months change in Rutherford class
Measured: 6 and 12 months
Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionJan 2013
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, MD, Principal investigator, Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221610
- Sponsor's protocol ID
- C1003
- Status last verified
- Feb 2015
- First submitted
- 14 Oct 2010
- 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
- A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).
- ClinicalTrials.gov ID
- NCT01221610
- Acronym / sponsor ID
- C1003
- Keywords
- Stenosis, Occlusions, SFA, PTA, POBA, DRB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 15 Oct 2010 (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, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Releasing Balloon | Experimental | Device: Passeo-18 Lux DRBPasseo-18 Lux Drug Releasing Balloon catheter |
| Standard PT A (POBA) | Active comparator | Device: Standard PTA (POBA)Uncoated Passeo-18 PTA catheter |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 50 years,
- Informed consent signed by patient prior to randomization
- Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
- Rutherford Class 2 - 5 in the target limb
- Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
Key exclusion criteria (18 listed)
- Co-morbid conditions limiting life expectancy ≤ 1 year
- Patient currently participating in another clinical trial
- Lesions which are untreatable with PTA or other interventional techniques
- The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
- Thrombus in the target vessel, documented by angiography
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 Balloon catheter | Device | Drug Releasing Balloon |
| Standard PTA (POBA)Also: Passeo-18 PTA catheter | Device | Standard PT A (POBA) |
Primary outcome
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA).
Time frame: 6 months
5 secondary outcomes
6 months binary restenosis rate
Time frame: 6 months
6 months and 12 months TLR rate
Time frame: 6 and 12 months
6 months and 12 months change in mean ABI
Time frame: 6 and 12 months
6 months and 12 months change in Rutherford class
Time frame: 6 and 12 months
Major Adverse Event rate at 6 and 12 months (procedure- or device-related death or amputation, target lesion thrombosis and clinically driven TLR)
Time frame: 6 and 12 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 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.
Dierk Scheinert, MD principal investigator
Park-Krankenhaus Leipzig GmbH, Leipzig, Germany
5 sites in 2 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 5 sites in 2 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 5 sites in Germany, 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?
Assessment of the 6 months late lumen loss in the target lesion measured by quantitative vascular angiography (QVA). (time frame: 6 months). 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 NCT01221610, 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.