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)

Last updated: December 28, 2024
Sponsor: Biotronik AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Peripheral Arterial Occlusive Disease

Claudication

Treatment

Oscar Peripheral Multifunctional Catheter

Clinical Study ID

NCT06758921
C2401
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject ≥18 years old

  2. Subject has provided written informed consent

  3. Subject has Rutherford classification 2 to 6

  4. Reference vessel diameter ≥2 and ≤7 mm

  5. Target lesion(s) has stenosis >70% by visual assessment

  6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-betweenwill be considered one lesion. Above the knee (ATK) group:

  7. Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)

  8. At least one below-knee artery patent to the ankle

  9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesionstenosis can be treated during the same procedure as per local standard of care. Theinflow lesion(s) must be treated first, prior to consideration of treatment of thetarget lesion. Subject can be enrolled if the inflow lesion(s) are treated andresult in ≤30% residual stenosis and no evidence of embolization or significantcomplications. Below the knee (BTK) group:

  10. Target lesions involve arteries below the tibial plateau

  11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion)resulting in ≤30% residual stenosis with no evidence of embolization or significantcomplications

Exclusion

Exclusion Criteria:

  1. Subject has a single target lesion that involves both ATK and BTK segments.

  2. Subject not suitable for receiving endovascular procedures of lower limb arteries.

  3. Prior planned major amputation in the target limb (i.e., above the ankle).

  4. Subject with previous bypass surgery of target vessel.

  5. History of any open surgical procedure within the past 30 days.

  6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTKprocedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure.

  7. Subject has Oscar IFU listed contraindication (such as uncorrected bleedingdisorders, sepsis).

  8. Subject under dialysis.

  9. Subject currently enrolled in another investigational device, biologic, or drugtrial in which the primary endpoint has not yet been reached.

  10. Subject lacking capacity to provide informed consent.

  11. Subject under judicial protection, tutorship, or curatorship (for France only).

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Oscar Peripheral Multifunctional Catheter
Phase:
Study Start date:
December 19, 2024
Estimated Completion Date:
January 20, 2026

Study 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).

Connect with a study center

  • LKH Univ. -Klinikum Graz, Ambulanz für Angiologie

    Graz, 8036
    Austria

    Active - Recruiting

  • Onze Lieve Vrouwziekenhuis

    Aalst, 9300
    Belgium

    Site Not Available

  • AZ Saint Blasius

    Dendermonde, 9200
    Belgium

    Active - Recruiting

  • ZOL Ziekenhuis Oost Limburg

    Genk, 3600
    Belgium

    Site Not Available

  • University Hospital Ghent

    Ghent, 9000
    Belgium

    Site Not Available

  • vzw AZ Groeninge

    Kortrijk, 8500
    Belgium

    Site Not Available

  • Hopital Saint Joseph

    Paris, 75674
    France

    Site Not Available

  • Karolinen-Hospital Arnsberg

    Arnsberg, 59759
    Germany

    Site Not Available

  • Sankt Gertrauden-Krankenhaus

    Berlin, 10713
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Semmelweis University

    Budapest, 1085
    Hungary

    Site Not Available

  • Policlinico Abano Terme

    Abano Terme, 35031
    Italy

    Site Not Available

  • Azienda Usl Toscana sud est

    Arezzo, 52100
    Italy

    Site Not Available

  • ospedaliero-universitaria Senese

    Siena, 53100
    Italy

    Site Not Available

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002
    Spain

    Site Not Available

  • Ospedale Regionale civico EOC di Lugano

    Lugano, 6962
    Switzerland

    Site Not Available

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