Phase
Condition
Circulation Disorders
Peripheral Arterial Occlusive Disease
Claudication
Treatment
Oscar Peripheral Multifunctional Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-betweenwill 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 lesionstenosis can be treated during the same procedure as per local standard of care. Theinflow lesion(s) must be treated first, prior to consideration of treatment of thetarget lesion. Subject can be enrolled if the inflow lesion(s) are treated andresult in ≤30% residual stenosis and no evidence of embolization or significantcomplications. 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 significantcomplications
Exclusion
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 BTKprocedure 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 bleedingdisorders, sepsis).
Subject under dialysis.
Subject currently enrolled in another investigational device, biologic, or drugtrial 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).
Study Design
Study Description
Connect with a study center
LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
Graz, 8036
AustriaActive - Recruiting
Onze Lieve Vrouwziekenhuis
Aalst, 9300
BelgiumSite Not Available
AZ Saint Blasius
Dendermonde, 9200
BelgiumActive - Recruiting
ZOL Ziekenhuis Oost Limburg
Genk, 3600
BelgiumSite Not Available
University Hospital Ghent
Ghent, 9000
BelgiumSite Not Available
vzw AZ Groeninge
Kortrijk, 8500
BelgiumSite Not Available
Hopital Saint Joseph
Paris, 75674
FranceSite Not Available
Karolinen-Hospital Arnsberg
Arnsberg, 59759
GermanySite Not Available
Sankt Gertrauden-Krankenhaus
Berlin, 10713
GermanySite Not Available
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Semmelweis University
Budapest, 1085
HungarySite Not Available
Policlinico Abano Terme
Abano Terme, 35031
ItalySite Not Available
Azienda Usl Toscana sud est
Arezzo, 52100
ItalySite Not Available
ospedaliero-universitaria Senese
Siena, 53100
ItalySite Not Available
Hospital Universitario de Guadalajara
Guadalajara, 19002
SpainSite Not Available
Ospedale Regionale civico EOC di Lugano
Lugano, 6962
SwitzerlandSite Not Available
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