A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases.
A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases. A total of 90 cases of patients, who are suitable to be treated with Peripheral Stent will be screened and enrolled according to the inclusion and exclusion criteria, and the lesion will be treated with GodenFlow Peripheral Stent System under the guidance of Digital Subtraction Angiography (DSA). Clinical and imaging follow-up was conducted 3 months and 6 months after surgery, The follow-ups mainly included clinical symptoms and signs, ankle-brachial index (ABI) and colour Doppler ultrasound, Computed Tomography Angiography (CTA), etc., for the sake of verifying the efficacy and safety of the device in treating patients with lower limb artery stenosis or occlusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Performing anaesthetic and pathological angiography according to the standard method, and select appropriate stent specifications according to the contrast results. After 1:1 pre-expansion, the stent system will be imparted into the lesion location, the stent will be distally positioned and released. The Tip head will be reset and the conveyor will be removed. If necessary, local re-expansion can be carried out. Remove the catheter and suture the wound. Postoperative treatment and anticoagulation.
Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
The incidence of TLR/ TVR
There should be no Target Lesion Revascularization (TLR) or Total Vascular Regeneration (TVR).
Time frame: 6 month
the successful implantation of the stent
The stent was placed in the superficial femoral artery after angiography observation, the blood flow was unobstructed, the stent position was appropriate, the wall was well adhered, and there was no displacement.
Time frame: immediate
the rate of patency
Under color Doppler ultrasound, the peak systolic velocity ratio (PSVR) ≤ 2.4
Time frame: at 3 months and 6 months after the surgery
Incidence of adverse events
Death, TLR, amputation, stent fracture, etc.
Time frame: 6 months after surgery
Clinical success
During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.
Time frame: 6 months after the surgery
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Frist Hospital of Lanzhou University
Lanzhou, Guansu, China
NOT_YET_RECRUITINGHainan General Hospital
Haikou, Hainan, China
RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe People's Hospital of Liaoning Province
Shenyang, Liaoning, China
RECRUITINGZhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGShanxi Provincial People's Hospital
Taiyuan, Shanxi, China
RECRUITING...and 2 more locations