Peripheral Arterial DiseaseNCT03121430
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion
A study testing Drug eluting peripheral vascular stent system and Nitinol Stent System in people with Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
Trial summary
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- What is being tested?
- Drug eluting peripheral vascular stent system and Nitinol Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2018to Feb 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
Who cannot join
- In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
- Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
- Subject with coagulation abnormalities should not be performed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu
About this study
Official title: The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
Read the detailed description
This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Being tested
- Drug eluting peripheral vascular stent system, Nitinol Stent System
- Keywords
- peripheral arterial disease, Drug eluting peripheral vascular stent system, primary patency
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting peripheral vascular stent systemDevice
Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Nitinol Stent SystemDevice
Also called Cordis Corporation
Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | subjects using the drug eluting peripheral vascular stent system Receives: Device: Drug eluting peripheral vascular stent system |
| Group B | Active comparator | subjects using the Nitinol Stent System (Cordis Corporation) Receives: Device: Nitinol Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency rate at 12 months after operation
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively
Measured: 12 months
Secondary outcomes (3)
primary patency rate at 6 months after operation
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively
Measured: 6 months
target lesion revascularization rate
subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms
Measured: Preoperative，up to 1 month，6 months，12 months
Stent fracture rate
using the Dual Fluoroscopic Imaging
Measured: 6 months、12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start22 Oct 2018
- Primary completionJul 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chen Zhong, Principal investigator, Beijing Anzhen HospitalGuo Wei, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121430
- Sponsor's protocol ID
- 2052108140
- Status last verified
- Feb 2019
- First submitted
- 9 Apr 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03121430
- Acronym / sponsor ID
- 2052108140
- Conditions
- Peripheral Arterial Disease, Superficial Femoral Artery Stenosis, Superficial Femoral Artery Occlusion
- Keywords
- peripheral arterial disease, Drug eluting peripheral vascular stent system, primary patency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Osmunda Medical Device Technology, Inc., Ltd.
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 20 Apr 2017 (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.
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
Detailed description
This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Drug eluting peripheral vascular stent systemsubjects using the drug eluting peripheral vascular stent system |
| Group B | Active comparator | Device: Nitinol Stent Systemsubjects using the Nitinol Stent System (Cordis Corporation) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent
Key exclusion criteria (3 listed)
- In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
- Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
- Subject with coagulation abnormalities should not be performed
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 |
|---|---|---|
| Drug eluting peripheral vascular stent systemDrug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA） | Device | Group A |
| Nitinol Stent SystemAlso: Cordis CorporationNitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA） | Device | Group B |
Primary outcome
primary patency rate at 12 months after operation
Time frame: 12 months
the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively
3 secondary outcomes
primary patency rate at 6 months after operation
Time frame: 6 months
target lesion revascularization rate
Time frame: Preoperative，up to 1 month，6 months，12 months
Stent fracture rate
Time frame: 6 months、12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Chen Zhong principal investigator
Beijing Anzhen Hospital
Guo Wei principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting peripheral vascular stent system and Nitinol Stent System in people with Peripheral Arterial Disease and Superficial Femoral Artery Stenosis, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site 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 3 inclusion and 3 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Gao Feng (+86 (0)10 8220-7036 ext. 823, md@osmundacn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency rate at 12 months after operation (time frame: 12 months). 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 18 Feb 2019.