Efficacy and Safety of RESOLUTE Zotarolimus-Eluting Stent in Treatment of Chinese Diabetic Coronary Lesions (RESOLUTE-DM)
|ClinicalTrials.gov Identifier: NCT01747356|
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : November 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Diabetes||Device: Resolute stent treatment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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
- 12-month TVF occurrence [ Time Frame: 12-month ]
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747356
|Ruijin Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200025|
|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|