Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.
A prospective, multi-centre, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. Approximately 158 subjects will be enrolled at 15 Chinese study sites. To confirm the safety and efficacy of the Passeo-18 Lux DCB for the interventional treatment of new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Paclitaxel releasing angioplasty balloon catheter is advanced through an introducer sheath and tracked over the wire until reaching the target lesion. The balloon can be precisely positioned by means of the radiopaque markers crimped on the inner shaft of the catheter. The catheter is dilated up to its intended diameter by inflating the balloon with a solution containing contrast media, causing a compression of the arterial plaque against the inner lining of the arterial wall and improving blood flow. After balloon inflation, the drug-carrier adheres to the arterial wall and facilitates the drug release to surrounding tissue. As there is no need for sustained release of Paclitaxel after the inflation, the drug carrier dissolves rapidly.
Fudan University affiliated Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Major Adverse Events
a composite of device- and procedure-related mortality, major target limb amputation and clinically-driven target lesion revascularization(TLR) within 12-months post-initial procedure.
Time frame: 12 months
Death of any cause
the all-cause mortality of subjects at 30 days, 6 months and 12 months after index procedure
Time frame: 30 days, 6 and 12 months
Target lesion revascularization
TLR,Target lesion revascularization.In the subjects experiencing target lesion revascularization, the two revascularizations were both judged as clinically driven target lesion revascularization.
Time frame: 30 days, 6 and 12 months
Clinically-driven target lesion revascularization
Defined as any re-intervention at the target lesion due to symptoms or drop of ABI/TBI of≥20% or \>0.15 when compared to post-procedure baseline ABI/TBI(Ankle Brachial Index/Toe Brachial Index). Clinically driven TLR will be adjudicated by an independent Clinical Event Committee
Time frame: 30 days, 6 and 12 months
Target vessel revascularization
TVR,Target vessel revascularization.The target vessel revascularization of subjects at 30 days, 6 months, and 12 months after index procedure.Defined as any re-intervention at the target vessel due to symptoms or drop of ABI/TBI of≥20% or \>0.15 when compared to post-procedure baseline ABI/TBI. Clinically driven TVR will be adjudicated by an independent Clinical Event Committee
Time frame: 30 days, 6 and 12 months
Clinically-driven target vessel revascularization
Defined as any re-intervention at the target vessel due to symptoms or drop of ABI/TBI of≥20% or \>0.15 when compared to post-procedure baseline ABI/TBI. Clinically driven TVR will be adjudicated by an independent Clinical Event Committee
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Time frame: 30 days, 6 and 12 months
Major target limb amputation
Surgical removal of tissue within the affected limb. * Above-knee amputation: amputation at a point above the knee * Below-knee amputation: amputation at a point below the knee
Time frame: 30 days, 6 and 12 months
Thrombosis at the target lesion site
Rapidly developing into total occlusion due to thrombosis confirmed by sudden onset of symptoms and recorded by Doppler ultrasound and/or angiography. Thrombosis can be classified as acute (\<1 day), subacute (1-30 days) and late (\> 30 days).
Time frame: 30 days, 6 and 12 months
Primary sustained clinical improvement
Primary sustained clinical improvement at 6 months and 12 months after index procedure is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without further endovascular or surgical revascularization procedure(s) at target lesion.
Time frame: 6 and 12 months
Secondary sustained clinical improvement
Secondary sustained clinical improvement at 6 months and 12 months after surgery defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including further endovascular or surgical revascularization procedures at target lesion.
Time frame: 6 and 12 months
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Binary restenosis of the target lesion determined by Duplex ultrasound at the time of re-intervention before 6 months and 12 months after index procedure or any prescheduled time point was judged by PSVR \> 2.4.
Time frame: 6 and 12 months
Walking capacity assessment by Walking Impairment Questionnaire
Changes in walking ability assessed with the Walking Impairment Questionnaire (WIQ) at baseline, 30 days, 6 months, and 12 months after index procedure.
Time frame: at baseline, 30 days, 6 and 12 months
Walking distance as assessed by 6 Minute Walk Test
Changes in the walking distance assessed with the 6-minute walking test (6MWT) at baseline, 30 days, 6 months, and 12 months after index procedure.
Time frame: at baseline, 30 days, 6 and 12 months
Quality of life assessment by EuroQol Five Dimensions(EQ5D) questionnaire
Changes in quality of life assessed with the EQ5D questionnaire at baseline, 30 days, 6 months, and 12 months after index procedure.
Time frame: at baseline, 30 days, 6 and 12 months
Device success
Device success referred to the intact investigational device successfully performing delivery, balloon inflation, deflation, and withdrawal without bursting below the rated burst pressure (RBP).
Time frame: during the procedure
Procedural success
Procedural success referred to residual stenosis ≤ 50% (for subjects without stent) or ≤ 30% (for subjects with stent) as accessed by the core laboratory.
Time frame: during the procedure
Clinical success
Clinical success, defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
Time frame: during the hospitalization