Iliac Artery StenosisNCT03687983
Safety and Efficacy Study of GoldenFlow Peripheral Stent System
A study testing GoldenFlow Peripheral Stent System in people with Iliac Artery Stenosis and Iliac Artery Occlusion, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iliac Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Stenosis
- What is being tested?
- GoldenFlow Peripheral Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 12 sitesChina
- Study dates
- 11 May 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 11 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality
Zhong Chen
- Active, not recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Changwei Liu
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Chang Shu
- Recruiting
Hainan General Hospital
Haikou, Hainan
Zhanxiang Xiao
- Not yet recruiting
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Bing Chen
- Not yet recruiting
The Frist Hospital of Lanzhou University
Lanzhou, Guansu
Wenhui Wang
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Xiwei Zhang
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
Weiguo Fu
- Recruiting
The People's Hospital of Liaoning Province
Shenyang, Liaoning
Danmin Wu
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Qiang Guan
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Xiangchen Dai
About this study
Official title: 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.
Read the 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.
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Being tested
- GoldenFlow Peripheral Stent System
- Keywords
- GoldenFlow Peripheral Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoldenFlow Peripheral Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants will be treated with GoldenFlow Peripheral Stent System. Receives: Device: GoldenFlow Peripheral Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of TLR/ TVR
There should be no Target Lesion Revascularization (TLR) or Total Vascular Regeneration (TVR).
Measured: 6 month
Secondary outcomes (4)
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.
Measured: immediate
the rate of patency
Under color Doppler ultrasound, the peak systolic velocity ratio (PSVR) ≤ 2.4
Measured: at 3 months and 6 months after the surgery
Incidence of adverse events
Death, TLR, amputation, stent fracture, etc.
Measured: 6 months after surgery
Clinical success
During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start11 May 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery StenosisStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhong Chen, Professor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687983
- Sponsor's protocol ID
- GF01
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of GoldenFlow Peripheral Stent System, A Prospective, Multi-center, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT03687983
- Acronym / sponsor ID
- GF01
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Keywords
- GoldenFlow Peripheral Stent System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: GoldenFlow Peripheral Stent SystemParticipants will be treated with GoldenFlow Peripheral Stent System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoldenFlow Peripheral Stent SystemPerforming 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. | Device | Intervention arm |
Primary outcome
The incidence of TLR/ TVR
Time frame: 6 month
There should be no Target Lesion Revascularization (TLR) or Total Vascular Regeneration (TVR).
4 secondary outcomes
the successful implantation of the stent
Time frame: immediate
the rate of patency
Time frame: at 3 months and 6 months after the surgery
Incidence of adverse events
Time frame: 6 months after surgery
Clinical success
Time frame: 6 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhong Chen, Professor principal investigator
Beijing Anzhen Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoldenFlow Peripheral Stent System in people with Iliac Artery Stenosis and Iliac Artery Occlusion, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Xia (+86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of TLR/ TVR (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.