Efficacy and Safety of RESOLUTE Zotarolimus-Eluting Stent in Treatment of Chinese Diabetic Coronary Lesions (RESOLUTE-DM)
Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used in treating patients with coronary artery disease (CAD). The State Food and Drug Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM patients and FDA has approved diabetic coronary lesion as a indication for using Resolute stent. Here the investigators set out a multicenter, non-inferiority study: the efficacy and safety of RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes (RESOLUTE-DIABETES CHINA) in purpose of identifying the efficacy and safety in Asia CAD correlated with diabetic population.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions|
- 12-month TVF occurrence [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
- Cardiac death (CD)
- Occurrence of myocardial infarction (Q wave or non-Q wave) in heart wall related to previously RESOLUTE stent treated coronary artery (LAD correspond to anterior wall, LCX correspond to lateral wall, RCA correspond to inferior wall).
- Clinical symptom related target vessel revascularization including PCI or coronary artery bypass grafting.
- Patient related adverse events [ Time Frame: 12-month ] [ Designated as safety issue: Yes ]
- Patient related adverse events including all-cause death, stroke, bleeding and revascularization. Revascularization includes all clinical symptom related or non-clinical symptom related PCI or coronary artery by-pass grafting in previously RESOLUTE treated lesion/vessel or untreated lesion/vessel.
- Stent thrombosis according to ARC definition.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Resolute stent treatment group
All patients will receive Resolute stent implantation to cure severe coronary atherosclerotic lesions.
RESOLUTE stent system specification (eluted zotarolimus 1.6μg/mm2):
After stent implantation, each patient will be followed up at time point of 30-day, 6-month and 12-month.
Duration of hospital stay Follow-up 1: 30days after procedure (±7 days) Follow-up 2: 6-month after procedure (±30 days) Follow-up 3: 12-month after procedure (±30 days)
Device: Resolute stent treatment
A well known coronary stent system that is produced by Medtronic Company and is also recommended by FDA for treating diabetic coronary lesion.
Other Name: Resolute Zotarolimus-eluting coronary stent system
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|Contact: Ruiyan Zhang, MD||86-21-64370045 ext email@example.com|
|Contact: Zhengbin Zhu, MD||86-21-64370045 ext firstname.lastname@example.org|
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Ruiyan Zhang, MD. 86-21-64370045 ext 665215 email@example.com|
|Contact: Zhengbin Zhu, MD. 86-21-64370045 ext 665380 firstname.lastname@example.org|
|Principal Investigator: Ruiyan Zhang, MD.|
|Study Director:||Weifeng Shen, MD.PhD.||Rui Jin hospital, Shanghai Jiao Tong University school of medcine|
|Principal Investigator:||Ruiyan Zhang, MD.||Rui Jin hospital, Shanghai Jiao Tong University school of medcine|