NOYA CoCr Biodegradable Coating Sirolimus-Eluting Coronary Stent System

Status Active, not recruiting

Clinical Trial Summary

Clinical Trial 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. ;

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

Clinical Trial Details

NCT number	NCT01226355
Study type	Interventional
Source	Medfavour (Beijing) Medical Co., Ltd
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 2009
Completion date	November 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00328315` - Cardiac SPECT With Rotating Slant Hole Collimator
Recruiting	`NCT02257710` - BIOFLOW-III UK Satellite Registry Orsiro Stent System	N/A
Active, not recruiting	`NCT02273648` - BIOTRONIK - BIOFLOW-III Registry French Satellite	N/A
Recruiting	`NCT01157455` - A Registry To Evaluate Safety And Effectiveness Of Everolimus Drug Eluting Stent For Coronary Revascularization	Phase 4
Completed	`NCT02028728` - BIOFLOW III Satellite-Italy Orsiro Stent System	N/A
Completed	`NCT02813473` - SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
Completed	`NCT05853250` - Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery	N/A
Recruiting	`NCT02635230` - What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.
Completed	`NCT01116882` - Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings	N/A
Completed	`NCT00920283` - COMPETE: A Clinical Evaluation of Chrono Carbostent Carbofilm™ Coated Stent	N/A
Completed	`NCT01700075` - Physical and Chemical Study of Atherosclerosis Mechanisms	Phase 4
Completed	`NCT00607178` - The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases	Phase 2/Phase 3
Completed	`NCT00607217` - The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases	Phase 2/Phase 3
Not yet recruiting	`NCT05486780` - The Effect of Digital Window on Day and Night Perception Status and Sleep Quality in Intensive Care Patients	N/A
Terminated	`NCT01665248` - Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina	N/A
Terminated	`NCT01612819` - DXR Stent(Previous Cilotax) Implantation Registry	N/A
Recruiting	`NCT02247492` - BIOFLOW-III VIP Russia Registry Orsiro Stent System