Coronary Artery DiseaseCREDIT-IINCT02057978
EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions.
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by JW Medical Systems Ltd at 1 site in China.
Trial summary
The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease
- What is being tested?
- EXCEL DES implatation and EXCEL-II DES implantation
- Type of treatment
- Surgery or procedure
- How many people
- 419 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2013to 25 Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
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: This study will plan for a total of 416 patients with primary, in situ coronary artery lesions (all of the patients was selected in different blood vessels, a total of up to two target disease Variable and each target lesion 1 stents, such as placing stents need more than one in the operation, require the use of the same brand of stents, mix does not recommend the same patients Other brand support, unless save extra stents.) Choose lesions reference diameter of 2.5 mm to 2.5 mm (visual), each lesion length 32 mm or less (visual), participants must conform to the standard can be selected.
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 two target lesions). 4.Lesion length ≤32mm. 5.RVD 2.5mm～4.0mm. 6.DS%≥70% by visual test. 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 the trial and willing to sign informed consent and accept clinical follow-up.
Who cannot join
- AMI within 7 days.
- CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
- Severe calcified lesion unable to predilate.
- The distortion of the stent was hampered by lesions.
- NYHA≥Ⅲ or LVEF<40%.
- Prior PCI within 1 year.
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- 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 Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )
The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.
Read the detailed description
The primary end point is to observe in-stent late lumenn loss after 9 months of the stent implantation.
This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of end points reach statictic significance.
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Being tested
- EXCEL DES implatation, EXCEL-II DES implantation
- Keywords
- Late Lumen Loss, MACE, Death, TLF, Thrombosis(definite or probable )
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCEL DES implatationProcedure or surgery
Also called Implant DES for CAD cases
Implant DES for CAD cases
EXCEL-II DES implantationProcedure or surgery
Also called Implant EXCEL-II DES for CAD cases
Implant DES for CAD cases
| Study group | Role | What they receive |
|---|---|---|
| EXCEL DES | Use EXCEL DES implatationas as control group,Implant DES for CAD cases Receives: Procedure: EXCEL DES implatation | |
| EXCEL-II DES | EXCEL-II DES implantation as control group,Implant DES for CAD cases Receives: Procedure: EXCEL-II DES implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
9 months in-stent late lumen loss
To observe in-stent late lumen loss after 9 months of stent implantation
Measured: 9 months
Secondary outcomes (3)
9-m in-segment diameter restenosis rate
9-m in stent, proximal stent edge, the distal edge segment defined in the restenosis rate, 9-m after lesions within the segment late lumen loss percentage and the diameter of the restenosis degree
Measured: 9 months
Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure
Device oriented composite of cardiac death, MI, or ischemia-driven TLR at 1m, 6m, 12m,18m and annually up to 5 yrs
Measured: 1m,6m,9m,12m,18m and annually to 5years
Rate of stent thrombosis
Definite and probable stent thrombosis according to ARC defination
Measured: 1m,6m,9m,12m,18m and annually up to 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study start8 Dec 2013
- Primary completion20 Oct 2017
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 419 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
- Han Yaling, PhD, Principal investigator, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057978
- Sponsor's protocol ID
- CREDIT-II-131105
- Acronym
- CREDIT-II
- Status last verified
- Apr 2023
- First submitted
- 12 Nov 2013
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu K, Han Y, Xu B, Yang Y, Wang G, Li H, Sun Y, Tao L, Wang H, Yuan Z, Liu H, Liu J, Jia Y, Ma G, Fu G, Li X, Li S, Wang S, Pu K; CREDIT 2 Investigators. Efficacy and safety of a second-generation biodegradable polymer sirolimus-eluting stent: One-year results of the CREDIT 2 trial. Cardiovasc Ther. 2018 Jun;36(3):e12327. doi: 10.1111/1755-5922.12327. Epub 2018 Mar 25.
PubMed 29493880