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Peripheral Arterial DiseaseBIOPACT-RCTNCT03884257

A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon.

A study testing Passeo-18 Lux treatment group and IN.PACT Admiral treatment group in people with Peripheral Arterial Disease, run by KANDO Research at 14 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. 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 treatment group and IN.PACT Admiral treatment group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
14 sitesin 4 countries
Study dates
18 Feb 2020to 6 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 is ≥18 years
  • Subject has Rutherford classification 2, 3 or 4
  • Subject has provided written informed consent and is willing to comply with study follow- up requirements
  • De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment
  • Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
  • Target vessel diameter ≥4mm and ≤7mm
Show all 14Show fewer
  • Target lesion must be stenotic lesion ≤180mm in length (one long lesion or tandem lesions) by investigator's visual estimate or a total occlusion ≤120mm in length by investigator's visual estimate.
  • Note: tandem lesions must have a total length of ≤180mm by visual estimate and be separated by ≤30mm
  • Target lesion must have angiographic evidence of ≥70% stenosis by investigator's visual estimation
  • Successful, uncomplicated crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above the knee (ATK) and without the use of re-entry devices
  • Target lesion is located at least 30mm from any stent, if target vessel was previously stented
  • After pre-dilatation, the target lesion is ≤50% residual stenosis, absence of a flow-limiting dissection and treatable with available device matrix
  • A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography
  • At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography

Who cannot join

  • Acute limb ischemia
  • Patient underwent an intervention involving the target vessel within the previous 90 days
  • Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or DCB within the previous 90 days
  • Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days
  • Women who are pregnant, breast-feeding or intend to become pregnant
  • Patient has life expectancy of less than 1 year
Show all 26Show fewer
  • Patient has a known allergy to contrast medium that cannot be adequately pre-medicated
  • Patient is allergic to all antiplatelet treatments
  • Patient is receiving immunosuppressant therapy
  • Patient has platelet count <100.000/mm3 or >700.000/mm3
  • Patient has history of gastrointestinal haemorrhage requiring a transfusion within 3 months prior to the study procedure
  • Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT)
  • Patient has history of stroke within the past 90 days
  • Patient has history of myocardial infarction within the past 30 days
  • Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or patient is planning to participate in such study prior to the completion of this study
  • Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
  • An intervention in the contralateral limb, planned within 30 days post-index procedure
  • Patient had previous bypass surgery of the target lesion
  • Patient had previous treatment of the target vessel with thrombolysis or surgery
  • Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
  • Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5mm)
  • Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices
  • Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
  • Presence of thrombus in the target vessel
  • Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications
  • Presence of an aortic, iliac or femoral artificial graft

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

Belgium6 sites

  • OLV Ziekenhuis Aalst

    Aalst, Oost-Vlaanderen, 9300

  • UZA

    Antwerp, Antwerp, 2650

  • Imelda Hospital

    Bonheiden, 2820

  • A.Z. Sint-Blasius

    Dendermonde, 9200

  • Z.O.L.

    Genk, 3600

  • R.Z. Heilig Hart

    Tienen, 3300

Other trials in Belgium

France4 sites

  • Clinique Rhône Durance

    Avignon, Provence-Alpes-Côte d'Azur Region, 84000

  • CHU Bordeaux

    Bordeaux, New Aquitaine, 33300

  • Hopital Paris Saint Joseph

    Paris, 75014

  • Clinique Pasteur

    Toulouse, Occitanie, 3100

Other trials in France

Austria2 sites

  • Medical University of Graz

    Graz, Graz, 8036

  • Hanusch Hospital

    Vienna, State of Vienna, 1140

Other trials in Austria

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, CH-1011

  • Triemlispital Zürich

    Zurich, Canton of Zurich, 8063

Other trials in Switzerland

About this study

Official title: A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon

The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally.

An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis.

Read more

The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure.

The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.

Read the detailed description

The objective of this clinical investigation is to assess the safety and efficacy of the Passeo-18 Lux DCB for the treatment of stenotic, restenotic or occlusive lesions of the femoropopliteal arteries. Furthermore a non-inferiority hypothesis will be tested with the IN.PACT Admiral DCB as comparator.

The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.

Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire.

During the procedure the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. A pre-dilatation with a standard non-drug-coated balloon will be performed followed by a dilatation of the lesion with either a Passeo-18 Lux (Biotronik) or an IN.PACT Admiral balloon (Medtronic). If dilatation was not successful (>30% stenosis, perforation, occlusive or flow limiting dissection) prolonged inflation should be attempted after which bail-out stenting with a bare nitinol stent is allowed in case of inadequate results.

The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1,6 and 12 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.

Being tested
Passeo-18 Lux treatment group, IN.PACT Admiral treatment group
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 treatment groupDevice

    Percutaneous endovascular angioplasty with the Passeo-18 lux

  • IN.PACT Admiral treatment groupDevice

    Percutaneous endovascular angioplasty with the IN.PACT Admiral

Study groups in NCT03884257
Study groupRoleWhat they receive
Passeo-18 Lux treatment groupExperimentalThese patients will be treated with the Passeo-18 Lux (Biotronik).
Receives: Device: Passeo-18 Lux treatment group
IN.PACT Admiral treatment groupActive comparatorThese patients will be treated with the IN.PACT Admiral (Medtronic).
Receives: Device: IN.PACT Admiral treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months post-procedure

    defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI.

    Measured: 12 months post-procedure

  2. Safety composite: number of participants who deceased, had major amputation, or target vessel revascularization (CD-TVR)

    composite of (1) freedom from device- and procedure-related death through 30 days post-index procedure, (2) freedom from major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure or (3) clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure

    Measured: 12 months post-procedure

Secondary outcomes (15)

  1. acute device success

    defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure

    Measured: Index procedure

  2. acute procedural success

    defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram

    Measured: index procedure

  3. freedom from all causes of death, freedom from major target limb amputation and freedom from CD-TVR through 30 days

    freedom from all cause death, major target limb amputation and CD-TVR through 30 days post-procedure

    Measured: 1 month post-procedure

  4. Sustained clinical improvement

    defined as freedom from major target limb amputation, TVR, worsening target limb Rutherford class (compared to baseline) and decrease in target limb ankle brachial index (ABI) or toe brachial index (TBI) ≥0.15 (compared to baseline)

    Measured: 6 and 12 months post-procedure

  5. freedom from major adverse events

    defined as composite of all-cause death, CD-TVR and major target limb amputation, or thrombosis at the target lesion

    Measured: 6 and 12 months post-procedure

  6. primary patency rate

    defined as a composite of freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab) through 12 months post-index procedure

    Measured: 6 and 12 months post-procedure

  7. freedom from target lesion revascularisation

    defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure

    Measured: 6 and 12 months post-procedure

  8. freedom from target vessel revascularisation

    defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure

    Measured: 6 and 12 months post-procedure

  9. freedom from binary restenosis

    defined as restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs

    Measured: 6 and 12 months post-procedure

  10. freedom from major target limb amputation

    defined as an amputation above the ankle in the target limb

    Measured: 6 and 12 months post-procedure

  11. freedom from thrombosis at target lesion

    freedom from thrombosis at target lesion

    Measured: 6 and 12 months post-procedure

  12. change in walking impairment questionnaire score from baseline to 6 and 12 months

    change in walking impairment questionnaire (WIQ) score from baseline to 6 and 12 months.

    The WIQ consists of 6 sections each consisting of multiple questions. Each question is scored from 0 to 4 (0 meaning a lot of problems and 4 no problems at all). The scores per section are summed up and recalculated to percentages (100% meaning very good and 0% meaning very bad). All the sections are averaged to give the final WIQ-score.

    Measured: 6 and 12 months post-procedure

  13. change in target limb rutherford class from baseline to 6 and 12 months

    change in target limb rutherford class from baseline to 6 and 12 months

    Measured: 6 and 12 months post-procedure

  14. change in target limb resting ABI or TBI from baseline to 6 and 12 months

    change in target limb resting ABI or TBI from baseline to 6 and 12 months

    Measured: 6 and 12 months post-procedure

  15. freedom from all causes of death

    freedom from all causes of death

    Measured: 6 and 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start18 Feb 2020
  3. Primary completion3 Sep 2022
  4. Study completion6 Oct 2026 (estimated)

Resources

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
Model description
The patients will be assigned at random to one of two treatment groups namely the Passeo-18 Lux or the IN.PACT Admiral treatment group.
Masking
Single blind
Who is masked
Participant
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03884257
Sponsor's protocol ID
BIOPACT-RCT
Acronym
BIOPACT-RCT
Status last verified
Jun 2026
First submitted
11 Mar 2019
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deloose K, Lansink W, Brodmann M, Werner M, Keirse K, Goueffic Y, Verbist J, Maene L, Hendriks J, Brunet J, Ducasse E, Levent K, Sauguet A, Deglise S, Vandael F. Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1855-1859. doi: 10.1007/s00270-022-03259-z. Epub 2022 Sep 4.

    PubMed 36058996

Questions about this trial

What is this clinical trial studying?

A study testing Passeo-18 Lux treatment group and IN.PACT Admiral treatment group in people with Peripheral Arterial Disease, run by KANDO Research at 14 sites in 4 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 14 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Belgium, France, Austria, Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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 clinically-driven target lesion revascularization (CD-TLR) at 12 months post-procedure (time frame: 12 months post-procedure). 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 NCT03884257, 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 10 Jun 2026.

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