EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III)
Information source: JW Medical Systems Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: EXCEL-II biodegradable polymer sirolimus-eluting stent (Device)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: JW Medical Systems Ltd Official(s) and/or principal investigator(s): yaling Han, MD, Principal Investigator, Affiliation: Shen yang Northern hospital
Overall contact: gangtao wang, Phone: +86 010 68068918, Email: gangtao.wang@jwmsgrp.com
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.
Clinical Details
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 design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: The Target Lesion Failure(TLF) as the primary endpoint at 12-month
Secondary outcome: Stent implantation success rateTLF, cardiovascular composite endpoints, ARC defined stent thrombosis
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 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.
Locations and Contacts
gangtao wang, Phone: +86 010 68068918, Email: gangtao.wang@jwmsgrp.com
Shenyang Northern Hospital, Shenyang, Liaoning 110015, China; Recruiting geng wang, PhD, Phone: +86 13309886393, Email: wanggeng69@hotmail.com he zhou, Phone: +86 13309888541, Email: fengying_6@163.com Wang Geng, PhD, Sub-Investigator
Additional Information
Starting date: January 2014
Last updated: January 2, 2014
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