Coronary Artery DiseaseNCT03716011
A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
A study testing EXCROSSAL in people with Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.
Trial summary
1. Prospective, randomized, multicenter clinical study 2. This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled. 3. EDC system (eCRF electronic data collection system) 4. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- EXCROSSAL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2018to 20 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years;
- De novo coronary artery primary lesions;
- Stable angina pectoris;
- Patients with coronary artery disease with similar symptoms of myocardial ischemia or angina;
- Suitable for PCI indication and suitable for the implant of EXCROSSAL stents.
- Able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and willing to accept the clinical follow-up; Imaging criteria The target lesion length≤ 60mm；Visual reference diameter of the vessel is 2.25-4.0mm;
Who cannot join
- Patients with acute myocardial infarction (AMI) within 7 days; Non-ST elevated ACS patients
- those who implanted any stent before;
- Left ventricular ejection score(LVEF) 30 %
- Patients with bleeding tendency or anticoagulation treatment contraindications and/or PCI contraindications or coagulopathy;
- There are other diseases such as cancer, malignant tumor, congestive heart failure, organ transplant, or candidate) or has a history of abuse (alcohol, cocaine, heroin, etc.), plan adherence is poor, or the life expectancy of less than 1 year;
- It is estimated that elective surgery patients within 12 months;
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- Other coronary lesions requiring staged intervention;
- If there are branches of blood vessels that need to be treated, the diameter of blood vessels ≥ 2.5 mm;
- The subject's compliance or the researcher's judgment was not suitable for the participants in the study;
- Pregnant or lactating persons; Imaging criteria
- 1. Left main disease, transplanted vessel lesions, stent restenosis; 2. The balloon cannot be predilated or/or the severe calcification lesion of rotatory failure; 3. The distortion of the stent is difficult to pass;
Trial locations and contacts
1 site in 1 country.
China1 site
JW Medical System
Beijing, Beijing Municipality, 100029
Wei M Fu, Bachelor, +86 10 50981788, wei.fu@jwmsgrp.com
Hao M Lu, Ph.D, +86 10 50981788, haolu04@yahoo.com.cn
About this study
Official title: A Large, Prospective, Randomized, Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System (Rapamycin) - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
- Prospective, randomized, multicenter clinical study
- This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled.
- EDC system (eCRF electronic data collection system)
- Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;
Read the detailed description
- Subjects are eligible for coronary intervention
- The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
- The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
- If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.
- Conditions
- Coronary Artery Disease
- Being tested
- EXCROSSAL
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCROSSALDevice
a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent
| Study group | Role | What they receive |
|---|---|---|
| DAPT 3M or DAPT 12M | Other | After stent implantation in DAPT 3M or DAPT 12M Receives: Device: EXCROSSAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure at 12-Month
The target lesion failure (TLF) rate at 12 months after operation involves cardiac death, target-vessel myocardial infarction, and clinical-symptom driven target vessel revascularization.
Measured: 12-month
Secondary outcomes (3)
MACE rate
Incidence of major adverse cardiac events (MACE) at different follow-up points of 1-month,3-month,6-month,12-month,24-month,36-month,48-month,60-montjh.
- Stent implantation success rate (covering the device success, the lesion success and the clinical success); 3. Target lesion failure (TLF) at 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation; 4. Subject-related cardio-clinical composite end points at the follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation, covering all-cause mortality, all myocardial infarctions and any revascularization; 5. The incidence of ARC-defined stent thrombosis events (defined, probable and non-excludable stent thrombosis in early, late, and delayed stages);
Measured: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Device success rates , lesion success rates , clinical success rates
The success of the instrument refers to the degree of stenosis in the final bracket after the instrument was implanted. Lt; 30 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.
The success of the lesion refers to the degree of ultimate diameter stenosis of the target lesion after the application of any interventional treatment. 50 %(visual), TIMI level 3 blood flow, and no residual stenosis and thrombus.
The success of surgery refers to the absence of major cardiac adverse events caused by ischemia during the patient's hospitalization(up to 7 days after surgery) based on the success of the lesion.
Measured: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Definite and probable stent thrombosis
According to ARC definition
Measured: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start20 Dec 2018 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Not applicable
- Intervention model
- Single group
- Model description
- the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
- Masking
- None (open label)
- Enrolment
- 2,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hao M Lu, Ph.D, Study director, Zhongshan hospital of ShangHai FuDan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716011
- Sponsor's protocol ID
- DREAM-201810
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 23 Oct 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large, Prospective, Randomized, Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System (Rapamycin) - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
- ClinicalTrials.gov ID
- NCT03716011
- Acronym / sponsor ID
- DREAM-201810
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 23 Oct 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.
- Prospective, randomized, multicenter clinical study
- This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled.
- EDC system (eCRF electronic data collection system)
- Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;
Detailed description
- Subjects are eligible for coronary intervention
- The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
- The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm
- If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the EXCROSSAL stent in CAD patients with 3-month DAPT or 12-month DAPT
| Arm | Type | Receives |
|---|---|---|
| DAPT 3M or DAPT 12M | Other | Device: EXCROSSALAfter stent implantation in DAPT 3M or DAPT 12M |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years and ≤75 years;
- De novo coronary artery primary lesions;
- Stable angina pectoris;
- Patients with coronary artery disease with similar symptoms of myocardial ischemia or angina;
- Suitable for PCI indication and suitable for the implant of EXCROSSAL stents.
Key exclusion criteria (11 listed)
- Patients with acute myocardial infarction (AMI) within 7 days; Non-ST elevated ACS patients
- those who implanted any stent before;
- Left ventricular ejection score(LVEF) 30 %
- Patients with bleeding tendency or anticoagulation treatment contraindications and/or PCI contraindications or coagulopathy;
- There are other diseases such as cancer, malignant tumor, congestive heart failure, organ transplant, or candidate) or has a history of abuse (alcohol, cocaine, heroin, etc.), plan adherence is poor, or the life expectancy of less than 1 year;
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 |
|---|---|---|
| EXCROSSALa Second Generation Biodegradable Polymer Sirolimus-Eluting Stent | Device | DAPT 3M or DAPT 12M |
Primary outcome
Target lesion failure at 12-Month
Time frame: 12-month
The target lesion failure (TLF) rate at 12 months after operation involves cardiac death, target-vessel myocardial infarction, and clinical-symptom driven target vessel revascularization.
3 secondary outcomes
MACE rate
Time frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Device success rates , lesion success rates , clinical success rates
Time frame: 1-month,3-month,6-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Definite and probable stent thrombosis
Time frame: 1-month,3-month, 12-month, 24-month, 36-month, 48-month and 60-month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Hao M Lu, Ph.D study director
Zhongshan hospital of ShangHai FuDan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXCROSSAL in people with Coronary Artery Disease, run by JW Medical Systems 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 6 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 23 Oct 2018. 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 Lei M Ge, Ph.D (+86 10 50981788 ext. 2, ge.lei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure at 12-Month (time frame: 12-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 23 Oct 2018.