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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oscar Peripheral Multifunctional Catheter.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Peripheral Arterial Disease(PAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, France, Germany, Hungary +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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).
Interventions
- Device 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).
Primary outcome measures
- Oscar Procedural success rate [Time frame: Index procedure]
Secondary outcome measures (11)
- Rate of (Serious) Adverse Device Effects (S)ADE [Time frame: discharge (30 days)]
- Rate of distal embolization [Time frame: Index procedure]
- Rate of target vessel rupture [Time frame: Index procedure]
- Rate of target vessel perforation [Time frame: Index procedure]
- Rate of target vessel acute occlusion [Time frame: Index procedure]
- Rate of Oscar PTA balloon related flow-limiting dissections [Time frame: Index procedure]
- Rate of peri-operative death (all-cause of death until discharge) [Time frame: discharge (30 days)]
- Rate of unplanned major amputation [Time frame: discharge (30 days)]
- Oscar crossing success [Time frame: Index procedure]
- Post-Oscar residual stenosis [Time frame: Index procedure]
- Final treatment residual stenosis (%) on the completion angiogram [Time frame: Index procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 5 centers
- Onze Lieve Vrouwziekenhuis — Aalst
- AZ Saint Blasius — Dendermonde
- ZOL Ziekenhuis Oost Limburg — Genk
- University Hospital Ghent — Ghent
- vzw AZ Groeninge — Kortrijk
Germany · 3 centers
- Karolinen-Hospital Arnsberg — Arnsberg
- Sankt Gertrauden-Krankenhaus — Berlin
- Universitätsklinikum Tübingen — Tübingen
Italy · 3 centers
- Policlinico Abano Terme — Abano Terme
- Azienda Usl Toscana sud est — Arezzo
- ospedaliero-universitaria Senese — Siena
Austria · 1 center
- LKH Univ. -Klinikum Graz, Ambulanz für Angiologie — Graz
France · 1 center
- Hopital Saint Joseph — Paris
Hungary · 1 center
- Semmelweis University — Budapest
Spain · 1 center
- Hospital Universitario de Guadalajara — Guadalajara
Switzerland · 1 center
- Ospedale Regionale civico EOC di Lugano — Lugano
Identifiers
NCT: NCT06758921 · C2401