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Clinical Trials in France / NCT06758921
Recruiting Observational

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)

NCT06758921 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-12-19
Last updated
2025-01-06

Condition(s) studied

Peripheral Arterial DiseasePeripheral Arterial Disease(PAD)

Investigational drug(s) / intervention(s)

Oscar Peripheral Multifunctional Catheter

Oscar Peripheral Multifunctional Catheter: 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).

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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-between will 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 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: 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 significant complications 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 BTK procedure 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 bleeding disorders, sepsis). 8. Subject under dialysis. 9. Subject currently enrolled in another investigational device, biologic, or drug trial 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).

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
LKH Univ. -Klinikum Graz, Ambulanz für Angiologie Graz Austria Recruiting
Onze Lieve Vrouwziekenhuis Aalst Belgium Not Yet Recruiting
AZ Saint Blasius Dendermonde Belgium Recruiting
ZOL Ziekenhuis Oost Limburg Genk Belgium Not Yet Recruiting
University Hospital Ghent Ghent Belgium Not Yet Recruiting
vzw AZ Groeninge Kortrijk Belgium Not Yet Recruiting
Hopital Saint Joseph Paris France Not Yet Recruiting
Karolinen-Hospital Arnsberg Arnsberg Germany Not Yet Recruiting
Sankt Gertrauden-Krankenhaus Berlin Germany Not Yet Recruiting
Universitätsklinikum Tübingen Tübingen Germany Not Yet Recruiting
Semmelweis University Budapest Hungary Not Yet Recruiting
Policlinico Abano Terme Abano Terme Italy Not Yet Recruiting
Azienda Usl Toscana sud est Arezzo Italy Not Yet Recruiting
ospedaliero-universitaria Senese Siena Italy Not Yet Recruiting
Hospital Universitario de Guadalajara Guadalajara Spain Not Yet Recruiting
Ospedale Regionale civico EOC di Lugano Lugano Switzerland Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06758921 on ClinicalTrials.gov ↗ ← All trials in France