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.
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).
Study Type
OBSERVATIONAL
Enrollment
200
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).
LKH Univ. -Klinikum Graz, Ambulanz für Angiologie
Graz, Austria
RECRUITINGOnze Lieve Vrouwziekenhuis
Aalst, Belgium
NOT_YET_RECRUITINGAZ Saint Blasius
Dendermonde, Belgium
RECRUITINGZOL Ziekenhuis Oost Limburg
Genk, Belgium
NOT_YET_RECRUITINGUniversity Hospital Ghent
Ghent, Belgium
NOT_YET_RECRUITINGvzw AZ Groeninge
Kortrijk, Belgium
NOT_YET_RECRUITINGHopital Saint Joseph
Paris, France
NOT_YET_RECRUITINGKarolinen-Hospital Arnsberg
Arnsberg, Germany
NOT_YET_RECRUITINGSankt Gertrauden-Krankenhaus
Berlin, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Germany
NOT_YET_RECRUITING...and 6 more locations
Oscar Procedural success rate
combination of Oscar technical success and absence of serious procedural complications
Time frame: Index procedure
Rate of (Serious) Adverse Device Effects (S)ADE
(Serious) Adverse Device Effects
Time frame: discharge (30 days)
Rate of distal embolization
Distal embolization
Time frame: Index procedure
Rate of target vessel rupture
Target vessel rupture
Time frame: Index procedure
Rate of target vessel perforation
Target vessel perforation
Time frame: Index procedure
Rate of target vessel acute occlusion
Target vessel acute occlusion
Time frame: Index procedure
Rate of Oscar PTA balloon related flow-limiting dissections
flow-limiting dissections defined as NHLBI grade ≥D
Time frame: Index procedure
Rate of peri-operative death (all-cause of death until discharge)
peri-operative death defined as all-cause of death until discharge
Time frame: discharge (30 days)
Rate of unplanned major amputation
unplanned major amputation
Time frame: discharge (30 days)
Oscar crossing success
angiographic confirmation of successful placement of a guidewire into the distal true lumen with Oscar support catheter used together with the dilator and/ or Oscar PTA balloon, and without any additional crossing/re-entry device.
Time frame: Index procedure
Post-Oscar residual stenosis
Post-Oscar residual stenosis (%)
Time frame: Index procedure
Final treatment residual stenosis (%) on the completion angiogram
Final residual stenosis (%) on the completion angiogram
Time frame: Index procedure
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