The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.
Xuanwu hospital
Beijing, China
rate of device success
Time frame: intraoperative
rate of procedural success
Time frame: intraoperative
rate of technical success
Time frame: intraoperative
rate of primary patency of target lesion
Time frame: 12 months
rate of primary patency of target lesion
Time frame: 24 months
rate of Clinically-driven TLR
Time frame: 12 months
rate of Clinically-driven TLR
Time frame: 24 months
rate of TLR
Time frame: 1 month
rate of TLR
Time frame: 12 months
rate of TLR
Time frame: 24 months
rate of Clinically-driven TVR
Time frame: 12 months
rate of Clinically-driven TVR
Time frame: 24 months
rate of TVR
Time frame: 1 month
rate of TVR
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Hospital of Chengde Medical College
Chengde, China
RECRUITINGThe Third People's Hospital of Chengdu
Chengdu, China
RECRUITINGThe First Affiliated Hospital of Dalian Medical University
Dalian, China
RECRUITINGThe Second Affiliated Hospital of Dalian Medical University
Dalian, China
RECRUITINGGuangzhou Huaqiao hospital
Guangzhou, China
RECRUITINGHospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
Guangzhou, China
RECRUITINGThe Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
RECRUITINGHangzhou First People's Hospital
Hangzhou, China
RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
RECRUITING...and 14 more locations
rate of TVR
Time frame: 24 months
change in Rutherford clinical category (target limb)
Time frame: 12 months
change in Rutherford clinical category (target limb)
Time frame: 24 months
change in ankle brachial index(ABI)
Time frame: 12 months
change in ankle brachial index(ABI)
Time frame: 24 months
rate of SAE
Time frame: 12 months
rate of SAE
Time frame: 24 months
rate of All-cause mortality
Time frame: 1 month
rate of All-cause mortality
Time frame: 12 months
rate of All-cause mortality
Time frame: 24 months
rate of Major amputation
Time frame: 1 month
rate of Major amputation
Time frame: 12 months
rate of Major amputation
Time frame: 24 months
rate of target lesion thrombosis
Time frame: 12 months
rate of target lesion thrombosis
Time frame: 24 months
Rate of adverse events
Time frame: intraoperative
Rate of adverse events
Time frame: 1 month
Rate of adverse events
Time frame: 12 months
Rate of adverse events
Time frame: 24 months