The objective of this clinical investigation is to evaluate, in a controlled setting, the 12 months safety and efficacy of the combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device, for PACSS 3 and PACSS 4 calcified femoropopliteal disease.
Study Type
OBSERVATIONAL
Enrollment
50
The combination of Shockwave Intravascular Lithotripsy and a polymer coated Drug Eluting Stent device for calcified femoropopliteal disease.
Klinikum Hochsauerland
Arnsberg, Germany
RECRUITINGUniversity Hospital Essen
Essen, Germany
RECRUITINGUniversity Hospital Eppendorf
Hamburg, Germany
Primary Patency
Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR)
Time frame: 12 months
Procedural success:
Defined as technical success and completion of the procedure without complications , meaning successful treatment of the vessels (technical success) in the absence of: * vessel rupture or perforation that require an intervention * need for emergency surgical revascularization of target limb * symptomatic thrombus or distal emboli that require surgical, mechanical, or pharmacologic means to improve flow and extend hospitalization * unplanned above the ankle amputation * major adverse cardiovascular events (defined as composite of total death, myocardial infarction, coronary revascularization and stroke).
Time frame: 30 days post procedure
Primary Patency
Defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50 systolic velocity ratio no greater than 2,4) and without Target Lesion Revascularization (TLR)
Time frame: 6 months
Target Lesion Revascularization (TLR)
Defined as the need for target lesion revascularization after index procedure.
Time frame: 6- and 12-months
Secondary Patency Rate
Defined as restored flow in the treated segment after occlusion or restenosis.
Time frame: 6- and 12-months
Amputation-free Survival rate
Defined as the time until a major amputation of the index limb and/or death of any cause, whichever occurred first.
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SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Germany
RECRUITINGSt. Marien Hospital
Lünen, Germany
NOT_YET_RECRUITINGUniversity Hospital LMU Munich
Munich, Germany
RECRUITINGTime frame: 6- and 12-months
Major Amputation Rate
Defined as any aboveankle amputation.
Time frame: 6- and 12-months
Clinical Success
Defined as an improvement of the Rutherford Becker Classification of one class or more, as compared to the preprocedure Rutherford Becker Classification.
Time frame: 6- and 12-months
Absence of Major Adverse Events (MAE)
Acute Coronary Syndrome, Stroke, Death, Major Amputation or TLR.
Time frame: 6- and 12-months