The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
PTA is an established alternative to open surgical bypass for the treatment of infrainginual disease of critical limb ischemia. DEBs are designed to promote arterial patency by reducing neointimal proliferation.
Study Type
OBSERVATIONAL
Enrollment
120
use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The second hospital of hebei medical university
Shijiazhuang, Hebei, China
Primary patency of target lesion.
The primary efficacy end point was primary patency at 12 months following the index procedure, defined as freedom from clinically driven target lesion revascularization and restenosis as determined by a duplex ultrasonography-derived peak systolic velocity ratio of ≤2.4
Time frame: 12 months
target lesion revascularization,target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Time frame: 6 months, 12 months
improvment in Rutherford stage
improvementin Rutherford stage is defined as an upward shift of at least 1 category on Rutherford classification as compared to baseline
Time frame: 6 months, 12 months
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to baseline
Time frame: 12 months
Device success during the operation
Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Time frame: during the operation
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The second affiliated hospital of Harbin medical university
Harbin, Heilongjiang, China
Wuhan central hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Nanjing, Zhejiang, China