Safety and Efficacy Study of GoldenFlow Peripheral Stent System

NCT03687983 | Unknown DMC

• 1 other identifier: GF01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 12

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.

Conditions

Iliac Artery Stenosis; Iliac Artery Occlusion; Femoral Artery Stenosis; Femoral Artery Occlusion; Popliteal Arterial Stenosis; Popliteal Artery Occlusion

Keywords

GoldenFlow Peripheral Stent System

Outcome Measures

Primary Outcomes (1)

• The incidence of TLR/ TVR

  There should be no Target Lesion Revascularization (TLR) or Total Vascular Regeneration (TVR).

  6 month

Secondary Outcomes (4)

• the successful implantation of the stent

  immediate

• the rate of patency

  at 3 months and 6 months after the surgery

• Incidence of adverse events

  6 months after surgery

• Clinical success

  6 months after the surgery

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants will be treated with GoldenFlow Peripheral Stent System.

Device: GoldenFlow Peripheral Stent System

Interventions

GoldenFlow Peripheral Stent System DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged greater than 18 years old and less than 80 years old.
• Patients who are able to understand the purpose of the trial, voluntary to participate and sign the informed consent.
• Patients who have good compliance and can complete follow-up.
• Life expectancy is more than one year.
• Rutherford-Becker classification\> grade2 and \<grade 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.
• 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.
• 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.
• The proximal inflow tract can undergo surgeries simultaneously, but the residual stenosis must \<20%, and without mural thrombus.

You may not qualify if:

• Patients who are not suitable for interventional vascular surgery.
• The target vessel was previously implanted with a stent, or have undergone an endovascular therapy or surgery within 3 months.
• Patients with an ipsilateral femoral aneurysm or femoral/popliteal artery with an aneurysm.
• Patients were diagnosed with severe lower limb diseases and previously planned to amputate.
• interventional coronary surgery should be performed within 30 days after surgery and patient who has had an interventional coronary surgery within past 7 days.
• Patients with known allergic reactions to antiplatelet agents, heparin, Nitinol or contrast agents.
• Pregnant and lactating women or women who cannot prevent pregnancy during the study period.
• 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.
• The patient had a cerebrovascular accident or major gastrointestinal bleeding within 6 months or prone to bleeding.
• 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.
• 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.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (12)

Beijing Anzhen Hospital, Capital Medical university

Beijing, Beijing Municipality, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

The Frist Hospital of Lanzhou University

Lanzhou, Guansu, China

NOT YET RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Study Officials

• Zhong Chen, Professor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Xia

CONTACT

+86 13760184511; xiaying@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: May 11, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 27, 2018

Record last verified: 2018-09

Locations

CN (12)