This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.
This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology
Study Type
OBSERVATIONAL
Enrollment
525
Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
Aalst, Belgium
GasthuisZusters Antwerpen (GZA) Ziekenhuizen
Antwerp, Belgium
Centre Hospitalier Régional (CHR) du Val de Sambre
Auvelais-Val de Sambre, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month
Time frame: From start up to 30 Days post procedure.
Total contrast media volume given during the procedure.
Time frame: During procedure
Total duration of the procedure
Time frame: During procedure
Total fluoroscopy time
Time frame: During procedure
Total radiation dose given
Time frame: During procedure
Technical success defined as a successful access and balloon angioplasty followed by stent placement with achieved recanalization determined by less than 30% residual stenosis by angiography at the baseline procedure.
Time frame: Pre- and post-procedure
Clinical success defined as technically successful procedure without the events considered in safety composite endpoint (all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month.
Time frame: During procedure
Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure.
Time frame: Up to 30 Days post procedure
Total acute device related complication rate defined as any device complication up to 1 month post procedure.
Time frame: Up to 30 Days post procedure
Ankle-Brachial Index (ABI) improvement at 30 days.
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Centre Hospitalier Universitaire (CHU) Liège
Liège, Belgium
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Time frame: 30 Days post procedure
Improvement of the Rutherford index at 30 days.
Time frame: 30Days post procedure
Walking distance at 30 days compared with walking distance before procedure.
Time frame: 30 Days post procedure
Bleeding complication as per BARC definitions.
Time frame: Up to 30 days post procedure