Actively Recruiting
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for Dilatation of Femoral, Popliteal, and Infrapopliteal Artery Lesions
Led by Biotronik AG · Updated on 2025-01-06
200
Participants Needed
16
Research Sites
4 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 patients with peripheral arterial disease affecting the femoral, popliteal, and infrapopliteal arteries. This prospective, multicenter, observational study aims to confirm procedural success and monitor in-hospital complications such as vessel perforation, rupture, acute occlusion, and distal embolization. The study includes patients with significant artery narrowing and specific lesion characteristics, who require endovascular intervention. The study uses 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 device is used to dilate lesions in the target arteries. The study focuses on procedural outcomes such as successful crossing of the target lesion, residual stenosis after vessel preparation, and absence of procedural complications. Treatments of inflow lesions may be performed before the target lesion treatment according to local standards. Participants will undergo the index procedure where procedural success and complications are closely monitored. Assessments include measuring procedural success rates, rates of adverse device effects, distal embolization, vessel rupture, perforation, and acute occlusion, as well as flow-limiting dissections and amputation occurrences within 30 days. Data on residual stenosis and crossing success will be collected. The study period extends until January 2026, with follow-up evaluations up to 30 days after discharge.
CONDITIONS
Brief 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 is 18 years old or older
- Subject has provided written informed consent
- Subject has Rutherford classification 2 to 6
- Reference vessel diameter is between 2 and 7 mm
- Target lesion(s) has stenosis greater than 70% by visual assessment
- Multiple consecutive single lesions with healthy segments of 3 cm or less between are considered one lesion
- Target lesions located in the superficial femoral artery or popliteal arteries above the tibial plateau (Above the knee group)
- At least one below-knee artery is patent to the ankle
- Successful treatment of inflow iliac stenosis to the target lesion with residual stenosis less than or equal to 30% and no significant complications
- Target lesions involve arteries below the tibial plateau (Below the knee group)
- Successful treatment of inflow vessel from ipsilateral iliac to target lesion with residual stenosis less than or equal to 30% and no significant complications
You will not qualify if you...
- Subject has a single target lesion involving both above and below the knee segments
- Subject is not suitable for endovascular procedures of lower limb arteries
- Prior planned major amputation above the ankle on the target limb
- Subject has previous bypass surgery of the target vessel
- History of any open surgical procedure within the past 30 days
- Planned vascular surgery within 30 days after the procedure on the target limb
- Subject has contraindications listed in the Oscar device instructions for use such as uncorrected bleeding disorders or sepsis
- Subject is on dialysis
- Subject currently enrolled in another investigational device, biologic, or drug trial with an ongoing primary endpoint
- Subject lacks capacity to provide informed consent
- Subject under judicial protection, tutorship, or curatorship (for France only)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo the procedure using the Oscar Peripheral Multifunctional Catheter to dilate lesions in the femoral, popliteal, and infrapopliteal arteries. This involves vessel preparation and balloon angioplasty as per device instructions.
1 visit (in-person)
Duration - Up to 30 days post-procedure
Participants are observed for safety and clinical outcomes following the procedure, monitoring for adverse device effects and vascular complications.
1 to 2 visits depending on clinical need
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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