Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries. The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
Study Type
OBSERVATIONAL
Enrollment
380
LKH Univ.-Klinikum Graz, Ambulanz für Angiologie
Graz, Austria
Ziekenhuis Oost Limburg
Genk, Genk, Belgium
OLV Ziekenhuis Aalst
Procedural success rate
Combination of technical success and absence of procedural complications
Time frame: Index Procedure
Procedure technical success rate
successful crossing and achievement of a final residual diameter stenosis of ≤30% of the treated target lesion on the procedural completion angiography
Time frame: Index Procedure
Rate of target lesion bailout stenting
Stented target lesion
Time frame: Index Procedure
Stented length
Stented length
Time frame: Index Procedure
Rate of PTA balloon related flow-limiting dissections
PTA balloon related flow-limiting dissections
Time frame: Index Procedure
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 acute occlusion
Acute occlusion
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Aalst, Belgium
A.Z. Sint-Blasius
Dendermonde, Belgium
University Hospital Ghent
Ghent, Belgium
vzw AZ Groeninge
Kortrijk, Belgium
Hopital Paris Saint Joseph
Paris, France
Universitätsklinikum Tübingen
Tübingen, Tübingen, Germany
Karolinen-Hospital, Klinikum Arnsberg
Arnsberg, Germany
Sank Gertrauden-Krankenhaus
Berlin, Germany
...and 7 more locations
Time frame: Index Procedure
Primary crossing success rate
Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy
Time frame: Index Procedure
Rate of Serious Adverse Device Effects
Serious Adverse Device Effects
Time frame: Index Procedure
Non-labor resource use
Devices use
Time frame: Index procedure until discharge