Clinical trial NCT01226355: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System
Official title: Clinical Trial Program of a Medical Instrument Product
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Diseases
Lead sponsor: Medfavour (Beijing) Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Division of Biometrics,National Center for Cardiovascular Diseases,China
First posted: 2010-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: In-stent late loss at 9-month
timeFrame: 270 days (±30days)
Secondary outcomes:
measure: MACEs found in follow-up period
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases
Study officials:
affiliation: Fu Wai Hospital, National Center for Cardiovascular Diseases,China
name: Runlin Gao, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.