The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
153
* Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting
* Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting.
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Ev. Krankenhaus Hubertus
Berlin, Germany
Klinikum der Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
Late Lumen Loss
Time frame: 6 months
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Klinikum Magdeburg
Magdeburg, Germany
Deutsches Herzzentrum München
München, Germany
RoMed Klinikum Rosenheim
Rosenheim, Germany