Clinical trial NCT02057978: EXCEL-II Stent Vesus EXCEL Stent to Treat the Patients With de Novo Coronary Artery Lesions.
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 )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Keywords: Late Lumen Loss
MACE
Death
TLF
Thrombosis(definite or probable )
Lead sponsor: JW Medical Systems Ltd
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

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.

Exclusion Criteria:

1. AMI within 7 days.
2. 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;
3. Severe calcified lesion unable to predilate.
4. The distortion of the stent was hampered by lesions.
5. NYHA≥Ⅲ or LVEF\<40%.
6. Prior PCI within 1 year.
7. Pregnancy or lactation, and planning pregnancy or lactation.
8. 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.
9. 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).
10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
11. Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
12. Before enrolling to participate in other clinical trials and not reached the primary endpoint.
13. Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.

Primary outcomes:
measure: 9 months in-stent late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: 9-m in-segment diameter restenosis rate
timeFrame: 9 months
measure: Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure
timeFrame: 1m,6m,9m,12m,18m and annually to 5years
measure: Rate of stent thrombosis
timeFrame: 1m,6m,9m,12m,18m and annually up to 5 yrs
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenyang Northern Hospital
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Han Yaling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.