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NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

Primary Purpose

Coronary Artery Diseases

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

stent

About this trial

This is an interventional treatment trial for Coronary Artery Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-75 years, men or unpregnant women;
Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
Total of lesion artery ≤2;
Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
Narrow level of lesion artery ≥70% in diameter (ocular estimate);
Amount of same stents implanted in a lesion artery ≤2;
Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
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:

Patients with acute myocardial infarction in 7 days;
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;
Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
In-stent restenosis lesions;
Patients with stent implantation in his/her coronary artery within recent one year;
Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );
Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;
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;
Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
Patients whose life expectancy less than 12 months;
Patients who are participating in other drugs or medical devices clinical trials;
Patients who can not comply with the clinical trial protocol;
Patients having a heart transplant.

Sites / Locations

Fuwai Hospital, National Center for Cardiovascular Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NOYA

Firebird2

Arm Description

implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent

implant Firebird2 drug-eluting stents Intervention: Device: stent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01226355

First Posted

October 21, 2010

Last Updated

May 20, 2012

Sponsor

Medfavour (Beijing) Medical Co., Ltd

Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital, Division of Biometrics,National Center for Cardiovascular Diseases,China

1. Study Identification

Unique Protocol Identification Number

NCT01226355

Brief Title

NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

Official Title

Clinical Trial Program of a Medical Instrument Product

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medfavour (Beijing) Medical Co., Ltd

Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital, Division of Biometrics,National Center for Cardiovascular Diseases,China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NOYA

Arm Type

Experimental

Arm Description

implant NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stents Intervention: Device: stent

Arm Title

Firebird2

Arm Type

Active Comparator

Arm Description

implant Firebird2 drug-eluting stents Intervention: Device: stent

Intervention Type

Device

Intervention Name(s)

stent

Other Intervention Name(s)

NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System, Firebird2 drug-eluting stents

Intervention Description

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.

Primary Outcome Measure Information:

Title

In-stent late loss at 9-month

Description

Time Frame

270 days (±30days)

Secondary Outcome Measure Information:

Title

MACEs found in follow-up period

Description

Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-75 years, men or unpregnant women; Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction; Total of lesion artery ≤2; Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate); Narrow level of lesion artery ≥70% in diameter (ocular estimate); Amount of same stents implanted in a lesion artery ≤2; Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique); 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: Patients with acute myocardial infarction in 7 days; 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; Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents; In-stent restenosis lesions; Patients with stent implantation in his/her coronary artery within recent one year; Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography ); Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl; 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; Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals; Patients whose life expectancy less than 12 months; Patients who are participating in other drugs or medical devices clinical trials; Patients who can not comply with the clinical trial protocol; Patients having a heart transplant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao, Professor

Organizational Affiliation

Fu Wai Hospital, National Center for Cardiovascular Diseases,China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fuwai Hospital, National Center for Cardiovascular Diseases

City

Beijing

ZIP/Postal Code

100037

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23171800

Citation

Xu B, Dou K, Yang Y, Lv S, Wang L, Wang H, Li Z, Wang L, Chen Y, Huo Y, Li W, Kirtane AJ, Gao R. Nine-month angiographic and 2-year clinical follow-up of the NOYA biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo native coronary artery lesions: the NOYA I trial. EuroIntervention. 2012 Nov 22;8(7):796-802. doi: 10.4244/EIJV8I7A122.

Results Reference

derived

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NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

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