NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

NCT01226355 | Unknown DMC

• 1 other identifier: FW2009-183
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Diseases

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• MACEs found in follow-up period

  5 years

Study Arms (2)

NOYA

EXPERIMENTAL

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

Device: stent

Firebird2

ACTIVE COMPARATOR

implant Firebird2 drug-eluting stents Intervention: Device: stent

Device: stent

Interventions

stent DEVICE

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.

Also known as: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System, Firebird2 drug-eluting stents

Firebird2; NOYA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medfavour (Beijing) Medical Co., Ltd: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Division of Biometrics,National Center for Cardiovascular Diseases,China: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, 100037, China

Location

Related Publications (1)

• 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.

  PMID: 23171800 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Runlin Gao, Professor

  Fu Wai Hospital, National Center for Cardiovascular Diseases,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2014
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

CN (1)