The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion\>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group
drug-coated balloon only in the active comparator group.
Renji Hospital
Shanghai, Shanghai Municipality, China
Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Time frame: 12-month
Freedom from major adverse limb events(MALEs)
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
Time frame: 12-month
Technical success
Defined as achievement of final residual diameter stenosis of \<30% on the procedural completion angiogram, using the assigned device only, whereas lesion success is defined as achievement of \<30% residual stenosis using any percutaneous method.
Time frame: Immediately after endovascular treatment
Procedural success
Defined as technical or device success without the occurrence of major adverse events
Time frame: During the hospital stay
Primary sustained clinical improvement
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients
Time frame: 24-month
Quality of life score
Quality of Life (QOL) score at 24 months; The minimum value is 1, and the maximum value is 7. The higher scores mean a better outcome.
Time frame: 24-month
EuroQol five dimensions questionnaire (EQ 5D-5L) score
EQ 5D-5L score at 24 months;The minimum value is 0, and the maximum value is 5. The higher scores mean a worse outcome.
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Time frame: 24-month