EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III) (CREDIT-III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02027870
Recruitment Status : Recruiting
First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
JW Medical Systems Ltd

Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

Detailed Description:
  1. A prospective, a single set, multicenter clinical trial;
  2. The primary in situ in patients with coronary heart disease;
  3. 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.)
  4. 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 Type : Observational [Patient Registry]
Estimated Enrollment : 621 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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)
Study Start Date : January 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2019

Group/Cohort Intervention/treatment
Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD
Device: EXCEL-II biodegradable polymer sirolimus-eluting stent
EXCEL-II biodegradable polymer sirolimus-eluting stent implantation

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Stent implantation success rate [ Time Frame: 5 Years ]
  2. TLF, cardiovascular composite endpoints, ARC defined stent thrombosis [ Time Frame: 30 days, 6 months, and 2-5 years ]

Biospecimen Retention:   None Retained
According to the CREATE (Multi - Center Registry of Excel Biodegradable Polymer Drug Eluting Stent) registration results show that ExcelTM drug-eluting stents implanted an average of 12 months, target lesion (TLF) the failure rate of 6.7%.Will this study expected target lesion group stent failure rate estimate of 6.7%, the target is 9.5%;Test hypothesis: bilateral 0.05% 0.05%, master degree, clinical follow-up requirements is more than 95%, this research need at least 829 patients, remove the CREDIT II randomized controlled study can provide the number of cases of test group 208 examples, this study still need to be included in the 621 patients.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the Patients With de Novo Coronary Artery Lesions

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 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.

Exclusion Criteria:

  1. AMI within 7 days.
  2. Left main lesion, transplant vasculopathy and stent restenosis lesion;
  3. Severe calcified lesion unable to predilate.
  4. The distortion of the stent was hampered by lesions.
  5. NYHA≥Ⅲ or LVEF<35%.
  6. Prior stenting within 1 year.
  7. Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
  8. Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers 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 is not complete person(ALT and AST were three times greater than the upper limit of normal).
  12. Rounding out the top participated in other clinical trials have not reached the main research the finish time limit.
  13. The researchers determine adherence is poor, could not finish my study in accordance with the requirements of the subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02027870

Contact: gangtao wang +86 010 68068918
Contact: yan lin +86 010 68068918

China, Liaoning
Shenyang Northern Hospital Recruiting
Shenyang, Liaoning, China, 110015
Contact: geng wang, PhD    +86 13309886393   
Contact: he zhou    +86 13309888541   
Sub-Investigator: Wang Geng, PhD         
Sponsors and Collaborators
JW Medical Systems Ltd
Principal Investigator: yaling Han, MD Shen yang Northern hospital

Responsible Party: JW Medical Systems Ltd Identifier: NCT02027870     History of Changes
Other Study ID Numbers: CREDIT-III-131113
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014

Keywords provided by JW Medical Systems Ltd:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Dermatologic Agents