A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.
This interventional study will collect data about the treatment of de novo lesions or restenotic lesions. Restenotic lesions that are previously DCB (drug coated balloon) treated or in-stent restenosis are excluded in this study. The primary objective of this randomized study is to compare the efficacy of the DCB (Legflow - Cardionovum) versus POBA for the treatment of de novo lesions or restenosis in the SFA and in the popliteal artery (segment P1 -P2) by assessing the binary restenosis rate with duplex ultrasonography at 12 months. The secondary endpoints are the assessment of the immediate procedural outcome, distribution of Rutherford, mortality, target lesion revascularization (TLR), target extremity revascularization (TER), amputation and anklebrachial index (ABI). For each patient enrolled, data will be collected up to 12 months after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
Percutaneous angioplasty performed with a standard balloon
ZNA Stuivenberg
Antwerp, Belgium
AZ Sint-Jan
Bruges, Belgium
ZOL (Ziekenhuis Oost-Limburg)
Genk, Belgium
Jessa hospital
Hasselt, Belgium
Efficacy measured by binary restenosis rate
Binary restenosis rate determined by duplex ultrasonography at 1, 6 and 12 months afte procedure. Binary restenosis is defined as a re-obstruction ≥50% of the target lesion (peak systolic velocity ratio \> 2.4).
Time frame: Until 12 months after procedure
Immediate procedural outcome of percutaneous balloon angioplasty
Investigator opinion of procedural and technical success of the percutaneous angioplasty. Opinion of investigator (yes/no) is recorded in the CRF for technical success and procedural success.
Time frame: From start of procedure surgery until completion of procedure surgery (Percutaneous balloon angioplasty)
Rutherford
Distribution of Rutherford stages during follow-up as compared to baseline.
Time frame: Baseline until 12 months after procedure
Mortality
30-day mortality, 6-months mortality and overall mortality at 12 months.
Time frame: Until 12 months after procedure
Repeated target lesion revascularization (TLR) rate
TLR is defined as a repeated procedure (endovascular or surgical) due to a problem arising from the lesion (+1 cm proximally and distally to include edge phenomena) initially treated in surviving patients with preserved limb.
Time frame: Until 12 months after procedure
Repeated target extremity revascularization (TER) rate
TER is defined as a procedure (endovascular or surgical) due to a problem arising in the ipsilateral traject (iliac, femoropopliteal and below the knee arteries) remote from the lesion initially treated in surviving patients with preserved limb.
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UZ Leuven
Leuven, Belgium
CHU Bordeaux
Bordeau, France
CHU Cermont-Ferrand
Clermont-Ferrand, France
CH Mont-de-Marsan
Mont-de-Marsan, France
Klinikum Arnsberg
Arnsberg, Germany
Time frame: Until 12 months after procedure
Minor and major amputation rate
Occurrence of minor (below the ankle) and major (above the ankle) amputations.
Time frame: Until 12 months after procedure
Ankle-Brachial Index (ABI)
Reporting of Ankle-Brachial Index compared to baseline
Time frame: Baseline until 12 months after procedure