Clinical trial NCT03687983: Safety and Efficacy Study of GoldenFlow Peripheral Stent System
Official title: Safety and Efficacy Study of GoldenFlow Peripheral Stent System, A Prospective, Multi-center, Single-Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iliac Artery Stenosis
Iliac Artery Occlusion
Femoral Artery Stenosis
Femoral Artery Occlusion
Popliteal Arterial Stenosis
Popliteal Artery Occlusion
Keywords: GoldenFlow Peripheral Stent System
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged greater than 18 years old and less than 80 years old.
2. Patients who are able to understand the purpose of the trial, voluntary to participate and sign the informed consent.
3. Patients who have good compliance and can complete follow-up.
4. Life expectancy is more than one year.
5. Rutherford-Becker classification\> grade2 and \<grade 6.
6. Stenosis or occlusion in the same vessel (one long lesion or several consecutive lesions), the length of lesions ≥20mm, the length of occlusion≤100mm, the length of stenosis ≤200mm, and the total length of lesions≤260mm. Reference vessel diameter \>4.0 mm.
7. Patients with bilateral lower limb lesions can be enrolled in, the investigator is the responsible person to determine which side of femoral artery should be enrolled, based on the length, the rate of stenosis and/or the degree of calcification of the lesion.
8. The conditions of the distal outflow tract and proximal inflow tract are good, the stenosis rate of all blood vessels of the inflow tract is \<50%, at least one third of the distal branches of the outflow tract is unobstructed (stenosis rate \<50%), for the sake of the blood flow in the distal outflow track.
9. The proximal inflow tract can undergo surgeries simultaneously, but the residual stenosis must \<20%, and without mural thrombus.

Exclusion Criteria:

1. Patients who are not suitable for interventional vascular surgery.
2. The target vessel was previously implanted with a stent, or have undergone an endovascular therapy or surgery within 3 months.
3. Patients with an ipsilateral femoral aneurysm or femoral/popliteal artery with an aneurysm.
4. Patients were diagnosed with severe lower limb diseases and previously planned to amputate.
5. interventional coronary surgery should be performed within 30 days after surgery and patient who has had an interventional coronary surgery within past 7 days.
6. Patients with known allergic reactions to antiplatelet agents, heparin, Nitinol or contrast agents.
7. Pregnant and lactating women or women who cannot prevent pregnancy during the study period.
8. The patient participated in clinical trials of other new drugs, biological products or medical devices during the screening period of this trial, or those who have participated in clinical trials of other drugs or medical devices but have not reached the main study endpoint.
9. The patient had a cerebrovascular accident or major gastrointestinal bleeding within 6 months or prone to bleeding.
10. Patients with severe liver and/or renal dysfunction (Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；serum total bilirubin (STB) was two times higher than the normal upper limit. Serum creatinine (Cr) \>177μmol/L) or with hematuria.
11. Patients are unable or unwilling to participate in the trial, or the investigator judged that the patient is not suitable to participate in the clinical study or the patient is without good compliance.

Primary outcomes:
measure: The incidence of TLR/ TVR
timeFrame: 6 month
Secondary outcomes:
measure: the successful implantation of the stent
timeFrame: immediate
measure: the rate of patency
timeFrame: at 3 months and 6 months after the surgery
measure: Incidence of adverse events
timeFrame: 6 months after surgery
measure: Clinical success
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical university
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Lanzhou
country: China
facility: The Frist Hospital of Lanzhou University
state: Guansu
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Zhong Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: