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)

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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).

Первичные конечные точки

• Oscar Procedural success rate [Срок оценки: Index procedure]

Вторичные конечные точки (11)

• Rate of (Serious) Adverse Device Effects (S)ADE [Срок оценки: discharge (30 days)]
• Rate of distal embolization [Срок оценки: Index procedure]
• Rate of target vessel rupture [Срок оценки: Index procedure]
• Rate of target vessel perforation [Срок оценки: Index procedure]
• Rate of target vessel acute occlusion [Срок оценки: Index procedure]
• Rate of Oscar PTA balloon related flow-limiting dissections [Срок оценки: Index procedure]
• Rate of peri-operative death (all-cause of death until discharge) [Срок оценки: discharge (30 days)]
• Rate of unplanned major amputation [Срок оценки: discharge (30 days)]
• Oscar crossing success [Срок оценки: Index procedure]
• Post-Oscar residual stenosis [Срок оценки: Index procedure]
• Final treatment residual stenosis (%) on the completion angiogram [Срок оценки: Index procedure]

Критерии участия

Критерии включения

• 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.

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

Критерии исключения

• 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.

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бельгия · 5 центров

• Onze Lieve Vrouwziekenhuis — Aalst
• AZ Saint Blasius — Dendermonde
• ZOL Ziekenhuis Oost Limburg — Genk
• University Hospital Ghent — Ghent
• vzw AZ Groeninge — Kortrijk

Германия · 3 центра

• Karolinen-Hospital Arnsberg — Arnsberg
• Sankt Gertrauden-Krankenhaus — Berlin
• Universitätsklinikum Tübingen — Tübingen

Италия · 3 центра

• Policlinico Abano Terme — Abano Terme
• Azienda Usl Toscana sud est — Arezzo
• ospedaliero-universitaria Senese — Siena

Австрия · 1 центр

• LKH Univ. -Klinikum Graz, Ambulanz für Angiologie — Graz

Франция · 1 центр

• Hopital Saint Joseph — Paris

Венгрия · 1 центр

• Semmelweis University — Budapest

Испания · 1 центр

• Hospital Universitario de Guadalajara — Guadalajara

Швейцария · 1 центр

• Ospedale Regionale civico EOC di Lugano — Lugano

Идентификаторы

NCT: NCT06758921 · C2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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