Actively Recruiting
Observational Study Evaluating the Oscar Peripheral Multifunctional Catheter for Treating Blockages in Femoral, Popliteal, and Infrapopliteal Arteries
Led by Biotronik AG · Updated on 2025-01-06
200
Participants Needed
16
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in treating lesions in the femoral, popliteal, and infrapopliteal arteries. This observational study focuses on patients with peripheral arterial disease and aims to confirm procedural success rates and monitor in-hospital complications related to endovascular interventions. The study includes a wide range of patients undergoing standard care practices for these artery lesions. The treatment involves using the Oscar Peripheral Multifunctional Catheter, which includes three components: the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The balloon can also be used separately but only with the pre-supplied support catheter. The procedures target lesions located either above or below the knee, and certain vascular inflow lesions may be treated during the same procedure according to local standard care. Participants will be involved in the study by undergoing endovascular procedures using the catheter, with researchers monitoring procedural success defined by lesion crossing and residual stenosis under 30%, and absence of complications like vessel perforation or embolization. The study collects data on procedural outcomes and complications during hospital stay. The primary outcome measure is the success rate of the procedure using the Oscar device. Participants must be adults aged 18 or older and will be observed during their treatment and hospitalization period.
CONDITIONS
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 (BIO-OSCAR First)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject 18 years old or older
- Subject has provided written informed consent
- Subject has Rutherford classification 2 to 6
- Reference vessel diameter between 2 and 7 mm
- Target lesion(s) has stenosis greater than 70% by visual assessment
- Multiple consecutive single lesions with a healthy segment of 3 cm or less in-between will be considered one lesion
- For above the knee 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 with residual stenosis 30% or less and no embolization or significant complications
- For below the knee group: Target lesions involve arteries below the tibial plateau
- Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in residual stenosis 30% or less with no embolization or significant complications
You will not qualify if you...
- Subject has a single target lesion that involves both above and below the knee segments
- Subject not suitable for receiving endovascular procedures of lower limb arteries
- Prior planned major amputation in the target limb (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 procedure on the target limb
- Subject has Oscar IFU listed contraindication such as uncorrected bleeding disorders or sepsis
- Subject under dialysis
- Subject currently enrolled in another investigational device, biologic, or drug trial with unresolved primary endpoint
- Subject lacking capacity to provide informed consent
- Subject under judicial protection, tutorship, or curatorship (for France only)
AI-Screening
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Trial Site Locations
Total: 16 locations
1
LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
Graz, Austria, 8036
Actively Recruiting
2
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
Not Yet Recruiting
3
AZ Saint Blasius
Dendermonde, Belgium, 9200
Actively Recruiting
4
ZOL Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Not Yet Recruiting
5
University Hospital Ghent
Ghent, Belgium, 9000
Not Yet Recruiting
6
vzw AZ Groeninge
Kortrijk, Belgium, 8500
Not Yet Recruiting
7
Hopital Saint Joseph
Paris, France, 75674
Not Yet Recruiting
8
Karolinen-Hospital Arnsberg
Arnsberg, Germany, 59759
Not Yet Recruiting
9
Sankt Gertrauden-Krankenhaus
Berlin, Germany, 10713
Not Yet Recruiting
10
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Not Yet Recruiting
11
Semmelweis University
Budapest, Hungary, 1085
Not Yet Recruiting
12
Policlinico Abano Terme
Abano Terme, Italy, 35031
Not Yet Recruiting
13
Azienda Usl Toscana sud est
Arezzo, Italy, 52100
Not Yet Recruiting
14
ospedaliero-universitaria Senese
Siena, Italy, 53100
Not Yet Recruiting
15
Hospital Universitario de Guadalajara
Guadalajara, Spain, 19002
Not Yet Recruiting
16
Ospedale Regionale civico EOC di Lugano
Lugano, Switzerland, 6962
Not Yet Recruiting
Research Team
H
Helene Kuissu, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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