Safety and Efficacy Study of GoldenFlow Peripheral Stent System
NCT ID: NCT03687983
Last Updated: 2018-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2016-05-11
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention arm
Participants will be treated with GoldenFlow Peripheral Stent System.
GoldenFlow Peripheral Stent System
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.
Interventions
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GoldenFlow Peripheral Stent System
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhong Chen, Professor
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Frist Hospital of Lanzhou University
Lanzhou, Guansu, China
Hainan General Hospital
Haikou, Hainan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhong Chen
Role: primary
Changwei Liu
Role: primary
Wenhui Wang
Role: primary
Zhanxiang Xiao
Role: primary
Chang Shu
Role: primary
Xiwei Zhang
Role: primary
Danmin Wu
Role: primary
Weiguo Fu
Role: primary
Qiang Guan
Role: primary
Xiangchen Dai
Role: primary
Bing Chen
Role: primary
Other Identifiers
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GF01
Identifier Type: -
Identifier Source: org_study_id
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