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AzTrials

Peripheral Arterial DiseaseNCT06758921

Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)

An observational study of Peripheral Arterial Disease and Peripheral Arterial Disease(PAD), run by Biotronik AG at 16 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oscar Peripheral Multifunctional Catheter
Type of treatment
Medical device
How many people
200 participants
Where
16 sitesin 8 countries
Study dates
19 Dec 2024to 20 Jan 2026
How long will I take part?
3 Days
Phase
Observational
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

Study population: A total of 200 patients will be enrolled, with approximately 100 subjects in ATK group, and 100 subjects in BTK group.

Who may be able to join

  • Subject ≥18 years old
  • Subject has provided written informed consent
  • Subject has Rutherford classification 2 to 6
  • Reference vessel diameter ≥2 and ≤7 mm
  • Target lesion(s) has stenosis >70% by visual assessment
  • Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between will be considered one lesion.
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  • Above the knee (ATK) group:
  • Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
  • At least one below-knee artery patent to the ankle
  • Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and result in ≤30% residual stenosis and no evidence of embolization or significant complications.
  • Below the knee (BTK) group:
  • Target lesions involve arteries below the tibial plateau
  • Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications

Who cannot join

  • Subject has a single target lesion that involves both ATK and BTK segments.
  • Subject not suitable for receiving endovascular procedures of lower limb arteries.
  • Prior planned major amputation in the target limb (i.e., above the ankle).
  • Subject with previous bypass surgery of target vessel.
  • History of any open surgical procedure within the past 30 days.
  • Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb.
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  • Note: The inflow vessels can be treated on the day of the procedure.
  • Subject has Oscar IFU listed contraindication (such as uncorrected bleeding disorders, sepsis).
  • Subject under dialysis.
  • Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached.
  • Subject lacking capacity to provide informed consent.
  • Subject under judicial protection, tutorship, or curatorship (for France only).

Trial locations and contacts

16 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Helene Kuissu, PharmD contact

+41 44 864 54 80

helene.kuissu@biotronik.com

16 sites in 8 countries

Belgium5 sites, 5 recruiting

  • Onze Lieve Vrouwziekenhuis

    Aalst, 9300

    Lieven Maene, MD

    Not yet recruiting

  • AZ Saint Blasius

    Dendermonde, 9200

    Koen Deloose, MD

    Recruiting

  • ZOL Ziekenhuis Oost Limburg

    Genk, 3600

    Wouter Lansink, MD

    Not yet recruiting

  • University Hospital Ghent

    Ghent, 9000

    Bernard Peeters, MD

    Not yet recruiting

  • vzw AZ Groeninge

    Kortrijk, 8500

    Philippe Lerut, MD

    Not yet recruiting

Other trials in Belgium

Germany3 sites, 3 recruiting

  • Karolinen-Hospital Arnsberg

    Arnsberg, 59759

    Michael Lichtenberg, Dr. Med

    Not yet recruiting

  • Sankt Gertrauden-Krankenhaus

    Berlin, 10713

    Ralf Langhoff, Dr. Med

    Not yet recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Jörg Schmehl, Dr. Med

    Not yet recruiting

Other trials in Germany

Italy3 sites, 3 recruiting

  • Policlinico Abano Terme

    Abano Terme, 35031

    Marco Manzi, MD

    Not yet recruiting

  • Azienda Usl Toscana sud est

    Arezzo, 52100

    Francesco Liistro, MD

    Not yet recruiting

  • ospedaliero-universitaria Senese

    Siena, 53100

    Gianmarco de Donato, Prof. MD

    Not yet recruiting

Other trials in Italy

Austria1 site, 1 recruiting

  • LKH Univ. -Klinikum Graz, Ambulanz für Angiologie

    Graz, 8036

    Marianne Brodmann, Prof. Dr. med

    Recruiting

Other trials in Austria

France1 site, 1 recruiting

  • Hopital Saint Joseph

    Paris, 75674

    Yann Goueffic, Prof. MD

    Not yet recruiting

Other trials in France

Hungary1 site, 1 recruiting

  • Semmelweis University

    Budapest, 1085

    Balazs Nemes, MD

    Not yet recruiting

Other trials in Hungary

Spain1 site, 1 recruiting

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

    Mercedes Guerra, MD

    Not yet recruiting

Other trials in Spain

Switzerland1 site, 1 recruiting

  • Ospedale Regionale civico EOC di Lugano

    Lugano, 6962

    Maria Antonella Ruffino, MD

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries

The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.

Read the detailed description

This is a prospective, multicenter, all-comers observational study. Primary endpoint was procedural success (defined as a combination of successful primary target lesion crossing, residual stenosis of ≤30% following vessel preparation and before definite treatment) and absence of procedural complications (defined as target vessel perforation or rupture, acute occlusion, and distal embolization).

Being tested
Oscar Peripheral Multifunctional Catheter
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.

  • Oscar Peripheral Multifunctional CatheterDevice

    Oscar Peripheral Multifunctional Catheter encompasses three components: (i) Oscar Support Catheter with integrated Lock Grip, (ii) Oscar Dilator and (iii) Oscar PTA Balloon.

    Single Oscar PTA Balloon is also available separately and can only be used together with the pre-supplied Oscar Support Catheter as indicated in the compatibility chart in the Instructions for Use (IFU).

What is being measured

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

  1. Oscar Procedural success rate

    combination of Oscar technical success and absence of serious procedural complications

    Measured: Index procedure

Secondary outcomes (11)

  1. Rate of (Serious) Adverse Device Effects (S)ADE

    (Serious) Adverse Device Effects

    Measured: discharge (30 days)

  2. Rate of distal embolization

    Distal embolization

    Measured: Index procedure

  3. Rate of target vessel rupture

    Target vessel rupture

    Measured: Index procedure

  4. Rate of target vessel perforation

    Target vessel perforation

    Measured: Index procedure

  5. Rate of target vessel acute occlusion

    Target vessel acute occlusion

    Measured: Index procedure

  6. Rate of Oscar PTA balloon related flow-limiting dissections

    flow-limiting dissections defined as NHLBI grade ≥D

    Measured: Index procedure

  7. Rate of peri-operative death (all-cause of death until discharge)

    peri-operative death defined as all-cause of death until discharge

    Measured: discharge (30 days)

  8. Rate of unplanned major amputation

    unplanned major amputation

    Measured: discharge (30 days)

  9. Oscar crossing success

    angiographic confirmation of successful placement of a guidewire into the distal true lumen with Oscar support catheter used together with the dilator and/ or Oscar PTA balloon, and without any additional crossing/re-entry device.

    Measured: Index procedure

  10. Post-Oscar residual stenosis

    Post-Oscar residual stenosis (%)

    Measured: Index procedure

  11. Final treatment residual stenosis (%) on the completion angiogram

    Final residual stenosis (%) on the completion angiogram

    Measured: Index procedure

Timeline

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

  1. First posted6 Jan 2025
  2. Study start19 Dec 2024
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Jan 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
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
3 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758921
Sponsor's protocol ID
C2401
Status last verified
Dec 2024
First submitted
31 Oct 2024
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not yet decided

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease and Peripheral Arterial Disease(PAD), run by Biotronik AG at 16 sites in 8 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 13 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, Germany, Italy, Austria, France and 3 more countries. 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?

Contact Helene Kuissu, PharmD (+41 44 864 54 80, helene.kuissu@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oscar Procedural success rate (time frame: Index procedure). 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 NCT06758921.

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 6 Jan 2025.

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