Coronary Artery DiseaseCREDIT-IIINCT02027870
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III)
An observational study of Coronary Artery Disease, run by JW Medical Systems Ltd at 1 site in China.
Trial summary
The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years. 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?
- EXCEL-II biodegradable polymer sirolimus-eluting stent
- Type of treatment
- Medical device
- How many people
- 625 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2014to 7 Nov 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: the Patients With de Novo Coronary Artery Lesions
Who may be able to join
- 1.18yrs≤Age≤75yrs . 2..stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed (myocardial ischemia; 3.De novo lesion at native coronary artery(Up to four target lesions). 4.Lesion length ≤60mm. 5.RVD 2.25mm～4.0mm. 6.DS%≥70% by visual estimation. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up.
- 9.To understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.
Who cannot join
- AMI within 7 days.
- Left main lesion, transplant vasculopathy and stent restenosis lesion;
- Severe calcified lesion unable to predilate.
- The distortion of the stent was hampered by lesions.
- NYHA≥Ⅲ or LVEF<35%.
- Prior PCI within 1 year.
Show all 13Show fewer
- Pregnancy or lactation, and planning pregnancy or lactation.
- Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
- There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
- To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
- Before enrolling to participate in other clinical trials and not reached the primary endpoint.
- Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery . (CREDIT-III Trial)
The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.
Read the detailed description
- A prospective, a single set, multicenter clinical trial;
- The primary in situ in patients with coronary heart disease;
- The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
- Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.
- Conditions
- Coronary Artery Disease
- Being tested
- EXCEL-II biodegradable polymer sirolimus-eluting stent
- Keywords
- DES, CAD, EXCEL-II, JWMS, PCI
- 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.
EXCEL-II biodegradable polymer sirolimus-eluting stentDevice
EXCEL-II biodegradable polymer sirolimus-eluting stent implantation
| Study group | Role | What they receive |
|---|---|---|
| EXCEL-II DES | Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD Receives: Device: EXCEL-II biodegradable polymer sirolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Target Lesion Failure(TLF) as the primary endpoint at 12-month
Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
Measured: 12months
Secondary outcomes (2)
Stent implantation success rate
Measured: 5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
Measured: 30 days, 6 months, and 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study start8 Jan 2014
- Primary completion30 Jul 2017
- Study completion7 Nov 2019
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 625 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- JW Medical Systems Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yaling Han, MD, Principal investigator, Shen yang Northern hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027870
- Sponsor's protocol ID
- CREDIT-III-131113
- Acronym
- CREDIT-III
- Status last verified
- Apr 2023
- First submitted
- 2 Jan 2014
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery . (CREDIT-III Trial)
- ClinicalTrials.gov ID
- NCT02027870
- Acronym / sponsor ID
- CREDIT-III / CREDIT-III-131113
- Conditions
- Coronary Artery Disease
- Keywords
- DES, CAD, EXCEL-II, JWMS, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- JW Medical Systems LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2014 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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.
The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.
Detailed description
- A prospective, a single set, multicenter clinical trial;
- The primary in situ in patients with coronary heart disease;
- The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
- Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXCEL-II DES | – | Device: EXCEL-II biodegradable polymer sirolimus-eluting stentUsing EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the Patients With de Novo Coronary Artery Lesions
Key inclusion criteria (2 listed)
- 1.18yrs≤Age≤75yrs . 2..stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed (myocardial ischemia; 3.De novo lesion at native coronary artery(Up to four target lesions). 4.Lesion length ≤60mm. 5.RVD 2.25mm～4.0mm. 6.DS%≥70% by visual estimation. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up.
- 9.To understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.
Key exclusion criteria (13 listed)
- AMI within 7 days.
- Left main lesion, transplant vasculopathy and stent restenosis lesion;
- Severe calcified lesion unable to predilate.
- The distortion of the stent was hampered by lesions.
- NYHA≥Ⅲ or LVEF<35%.
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 |
|---|---|---|
| EXCEL-II biodegradable polymer sirolimus-eluting stentEXCEL-II biodegradable polymer sirolimus-eluting stent implantation | Device | EXCEL-II DES |
Primary outcome
The Target Lesion Failure(TLF) as the primary endpoint at 12-month
Time frame: 12months
Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
2 secondary outcomes
Stent implantation success rate
Time frame: 5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
Time frame: 30 days, 6 months, and 2-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
yaling Han, MD principal investigator
Shen yang Northern hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 26 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Target Lesion Failure(TLF) as the primary endpoint at 12-month (time frame: 12months). 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 26 Apr 2023.