Coronary Artery StenosisPhase 3NCT03185221
Cordimax China Post Market Surveillance
A Phase 3 study testing Cordimax and XIENCE V in people with Coronary Artery Stenosis, run by Shandong Branden Med.Device Co.,Ltd at 1 site in China.
Trial summary
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- Cordimax and XIENCE V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,660 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2013to 20 Jun 2020
- Phase
- Phase 3
- 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
- age 18 years old or more
- patients with symptomatic coronary artery disease
- adapt to the DES treatment according to guide
- with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
- patients willing to participate and sign in research
Who cannot join
- Women in pregnancy or lactation
- Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
- Patients were banned to use the antiplatelet and/or anticoagulant therapy
- Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
- Patients who must stop clopidogrel to accept a elective surgery
- patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Fudan University
Beijing, Beijing Municipality, 100032
About this study
Official title: Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world.
Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
Read the detailed description
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System.
The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 4 mm.
All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT.
All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .
- Conditions
- Coronary Artery Stenosis
- Being tested
- Cordimax, XIENCE V
- Keywords
- Stents Coronary Artery Disease
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CordimaxDevice
One rapamycin eluting stent for treating the adapted coronary patients
XIENCE VDevice
One everolimus eluting stent for treating the adapted coronary patients
| Study group | Role | What they receive |
|---|---|---|
| Cordimax | Experimental | Rapamycin Eluting Coronary Stent Receives: Device: Cordimax |
| XIENCE V | Active comparator | Everolimus Eluting Coronary Stent Receives: Device: XIENCE V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure(TLF)
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization
Measured: at 1st year
Secondary outcomes (6)
Thrombotic events incidence
According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d
Measured: at30 60 90 days and 1st 2st 3st 4st 5st year
Major adverse cardiovascular events (MACE)
Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven
Measured: at30 60 90 days and 1st 2st 3st 4st 5st year
The Success Rate of Stent Placement
The stent can arrive and through the target lesion area, and can be expanded finally.
Measured: in the operation
Operation Success Rate
After stent implantation, stent diameter stenosis < 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen.
Measured: 0 to 24 hours after intervention
Cost of the hospitalization
The total expenses in the process of operation
Measured: 0 to 24hours after discharge
Length of stay
The total time consumption in the process of operation
Measured: 0 to 24 hours after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start20 Jun 2013
- Primary completion20 Jun 2019 (estimated)
- Study completion20 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185221
- Sponsor's protocol ID
- Branden-456
- Status last verified
- Jun 2017
- First submitted
- 16 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
- ClinicalTrials.gov ID
- NCT03185221
- Acronym / sponsor ID
- Branden-456
- Conditions
- Coronary Artery Stenosis
- Keywords
- Stents Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,660 participants (actual)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 20 Jun 2013 (actual)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 20 Jun 2020 (estimated)
- First posted
- 14 Jun 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.
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world.
Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
Detailed description
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System.
The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 4 mm.
All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT.
All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cordimax | Experimental | Device: CordimaxRapamycin Eluting Coronary Stent |
| XIENCE V | Active comparator | Device: XIENCE VEverolimus Eluting Coronary Stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 years old or more
- patients with symptomatic coronary artery disease
- adapt to the DES treatment according to guide
- with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
- patients willing to participate and sign in research
Key exclusion criteria (6 listed)
- Women in pregnancy or lactation
- Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
- Patients were banned to use the antiplatelet and/or anticoagulant therapy
- Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
- Patients who must stop clopidogrel to accept a elective surgery
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 |
|---|---|---|
| CordimaxOne rapamycin eluting stent for treating the adapted coronary patients | Device | Cordimax |
| XIENCE VOne everolimus eluting stent for treating the adapted coronary patients | Device | XIENCE V |
Primary outcome
Target Lesion Failure(TLF)
Time frame: at 1st year
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization
6 secondary outcomes
Thrombotic events incidence
Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year
Major adverse cardiovascular events (MACE)
Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year
The Success Rate of Stent Placement
Time frame: in the operation
Operation Success Rate
Time frame: 0 to 24 hours after intervention
Cost of the hospitalization
Time frame: 0 to 24hours after discharge
Length of stay
Time frame: 0 to 24 hours after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Junbo Ge principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cordimax and XIENCE V in people with Coronary Artery Stenosis, run by Shandong Branden Med.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 5 inclusion and 6 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 14 Jun 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure(TLF) (time frame: at 1st year). 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 14 Jun 2017.