NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

Coronary Artery Diseases Clinical Trial

Official title:

Clinical Trial Program of a Medical Instrument Product

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01226355
• Other study ID #: FW2009-183
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2010
• Last updated: May 20, 2012
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: May 2012
• Source: Medfavour (Beijing) Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.

Description:

A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2014
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years, men or unpregnant women;

2. Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;

3. Total of lesion artery =2;

4. Lesion artery =30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);

5. Narrow level of lesion artery =70% in diameter (ocular estimate);

6. Amount of same stents implanted in a lesion artery =2;

7. Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);

8. Patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept follow-up.

Exclusion Criteria:

1. Patients with acute myocardial infarction in 7 days;

2. Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter =2.25mm;

3. Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;

4. In-stent restenosis lesions;

5. Patients with stent implantation in his/her coronary artery within recent one year;

6. Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );

7. Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;

8. Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;

9. Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;

10. Patients whose life expectancy less than 12 months;

11. Patients who are participating in other drugs or medical devices clinical trials;

12. Patients who can not comply with the clinical trial protocol;

13. Patients having a heart transplant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• stent
NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd. Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Medfavour (Beijing) Medical Co., Ltd	Chinese Academy of Medical Sciences, Fuwai Hospital, Division of Biometrics,National Center for Cardiovascular Diseases,China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late loss at 9-month	Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents.	270 days (±30days)	Yes
Secondary	MACEs found in follow-up period	Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents.	5 years	Yes