Safety and Efficacy Study of GoldenFlow Peripheral Stent System

September 26, 2018 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

Safety and Efficacy Study of GoldenFlow Peripheral Stent System, A Prospective, Multi-center, Single-Arm Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Changwei Liu
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
          • Zhong Chen
      • Beijing, Beijing, China
        • Active, not recruiting
        • Chinese PLA General Hospital
    • Guansu
      • Lanzhou, Guansu, China
        • Not yet recruiting
        • The Frist Hospital of Lanzhou University
        • Contact:
          • Wenhui Wang
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Hainan General Hospital
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The People's Hospital of Liaoning Province
        • Contact:
          • Danmin Wu
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
          • Qiang Guan
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • the Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention arm
Participants will be treated with GoldenFlow Peripheral Stent System.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of TLR/ TVR
Time Frame: 6 month
There should be no Target Lesion Revascularization (TLR) or Total Vascular Regeneration (TVR).
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the successful implantation of the stent
Time Frame: immediate
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.
immediate
the rate of patency
Time Frame: at 3 months and 6 months after the surgery
Under color Doppler ultrasound, the peak systolic velocity ratio (PSVR) ≤ 2.4
at 3 months and 6 months after the surgery
Incidence of adverse events
Time Frame: 6 months after surgery
Death, TLR, amputation, stent fracture, etc.
6 months after surgery
Clinical success
Time Frame: 6 months after the surgery
During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.
6 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: zhong chen, Professor, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GF01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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