This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
224
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA)
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA)
Xuanwu Hospital, Capital Medical University
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Changzhou First People's Hospital
Changzhou, China
primary patency rate at 12 months after operation
Time frame: 12 months
success rate of the device
Time frame: Intraoperation
success rate of the technique
Time frame: post operation
rate of CD-TLR
Time frame: 6 months,12 months
ABI
Time frame: post operation, 6 months,12 months
Rutherford classification
Time frame: post operation, 6 months,12 months
the incidence of major adverse events
Time frame: 30 days, 6 months,12 months
the rate of target limb major amputation
Time frame: 30 days, 6 months,12 months
the incidence of adverse events
Time frame: Intraoperation, post operation, 30 days, 6 months,12 months
the incidence of SAE
Time frame: Intraoperation, post operation, 30 days, 6 months,12 months
the rate of device defect
Time frame: Intraoperation, 12 months
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Changzhou Second People's Hospital
Changzhou, China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Anhui Provincial Hospital
Hefei, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
Affiliated Hospital of Qingdao University
Qingdao, China
Shanghai Ninth People's Hospital
Shanghai, China
...and 2 more locations