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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 rate

TLF, 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

Page last updated: August 23, 2015

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