Ignite Creation Date:
2024-05-06 @ 1:09 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01747356
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2012-12-09
Brief Title:
Efficacy and Safety of RESOLUTE Zotarolimus-Eluting Stent in Treatment of Chinese Diabetic Coronary Lesions
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESOLUTE-DM
Brief Summary:
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
Detailed Description:
STUDY DESIGN This study is a multicenter registry held in China main land A total of 1000 diabetic patients with coronary artery disease and receive RESOLUTE zotarolimus eluting stents implantation from 20 study centers will be enrolled The estimated follow-up duration is 12-month Clinical events laboratory examination results and related data will be recorded in the time point of 30 days 6-month and 12-month Patients who quit half-way cannot be replaced and the reasons should be reported
All data collection and management analysis and supervision will be accomplished by independent study institution
STUDY POPULATION All 1000 patients enrolled in this registry and receive RESOLUTE zotarolimus eluting stents implantation should be diagnosed as type 2 diabetes previously or during hospital before PCI procedure Glucose level fast and 2h post-meal HbA1c and all medications should be recorded before enrollment and all through follow-up period
STUDY DURATION The estimated follow-up duration is 12-month Clinical events laboratory examination results and related data will be recorded in the time point of 30 days 6-month and 12-month
STUDY PROCESS Patients sign the informed consent and should be provided with a signed and dated copy
Interventional process from PCI to discharge The stent implantation process should be consistent with the international standard procedure guideline Other PCI techniques including atherectomy intravascular ultrasound optical interference laminagraphy pressure guide wire technology intra-aortic balloon counterpulsation and so on can be used according to the opinion of the operators
Antiplatelet drugs and anticoagulant therapy is determined by each study center The use of glucoprotein ⅡbⅢa inhibitor and other antiplatelet drugs such as ciloprost is determined by the operators
The standard of instrument success and procedure success
Standard of instrument success After successful convery of RESOLUTE stent system and successful implantation the remaining stenosis rate in diameter less than 50 with TIMI grade 3 without using other interventional techniques
Standard of procedure success With all kinds of interventional therapy the remaining stenosis rate in diameter is less than 20 ocular estimation without occurrence of death myocardial infarction and target lesion revascularization during hospitalization
Post-procedural follow-up After stent implantation each patient will be followed up at time point of 30-day 6-month and 12-month The follow-up includes angina evaluation according to Canadian Cardiovascular Society Classification and Braunwald Classification of unstable angina Glycosylated hemoglobin HbA1c fast glucose level Total Cholesterol LDL level Clinical events including death myocardial infarction ST stroke bleeding and any revascularization
Quantification of angiography QCA All angiographic results of baseline and immediately post-procedure will be sent to the laboratory of SNOC medical technology to do an independent QCA analysis with MEDCON TCS QCA software Reference vessel diameter RVD minimal lumen diameter MLD stent length stenosis percent in diameter and other related data will be reevaluated
ADVERSE EVENT REPORT PROCESS Adverse events supervision committee The Clinical Events Committee CEC is composed of interventional experts who have no relationship with Medtronic and all study centers and they will not directly attend the current study CEC will supervise and determine the events according to the current guidelines as well as the regulations that immobilized to the current study CEC will also do the inspection and determination according to the study endpoints that are based on the systemic analysis of the raw data collection electrocardiogram angiography and so on to ensure a central systemic standardized independent and impartial evaluate process
Definition of adverse events and coping management The adverse events refers to any unacceptable clinical events which may resulted from the instruments Zotarolimus operative procedure or drugs that are necessary for the study for example aspirin or Plavix
Self-consciously reported adverse events are encouraged in the current study Any time during the follow-up patients can inquire the information about likely adverse events directly to the main center If an adverse event is determined all the related information should be collected and related tables should be fulfilled immediately by the researchers
Severe adverse event SAE Severe adverse events refer to death life-threatening disease or injury permanent impairment to body structure or function prolonged hospital stay or hospitalization congenital anomaly is induced and events likely judged by CEC All the severe adverse events should be reported as SAE
Any time SAE occurs regardless of the relationship with the study product proper therapeutic measure should be loading on immediately At the meantime a case report including SAE specific report table should be sent to the main researcher register and supervisor by telephone or email within 24 hours The report to related administration within prescriptive time window should be also carried out in order to assist the inquiry held by the competent department and take proper strategy to redress the protocol and ensure prevention measure
Follow-up duration after adverse events All adverse events should be followed-up and treated until resolved or acquire a stable endpoint
Premature termination of the study case may resulted by the following reasons
1 Patents decision to quit
2 Fail to follow-up a written form mail of verification should be sent to the patient who cant be contacted by telephone If all the communication fails the case should be marked as fail to follow-up
Reasons of quit
It should be encouraged to provide information during follow-up If the patient decide to quit the reason should be recorded immediately Possible reasons may include
1 Patients decision and informed consent retracted
2 Adverse events patients should be followed up until fully recovered or acquire clinically stable
3Fail to follow-up a written form mail of verification should be sent to the patient who cant be contacted by telephone If all the communication fails the case should be marked as fail to follow-up Once there is a chance to confirm patients condition it should also be recorded
Interrupted cases should be included for research analysis
All data collection and management analysis and supervision will be accomplished by independent study institution
STUDY POPULATION All 1000 patients enrolled in this registry and receive RESOLUTE zotarolimus eluting stents implantation should be diagnosed as type 2 diabetes previously or during hospital before PCI procedure Glucose level fast and 2h post-meal HbA1c and all medications should be recorded before enrollment and all through follow-up period
STUDY DURATION The estimated follow-up duration is 12-month Clinical events laboratory examination results and related data will be recorded in the time point of 30 days 6-month and 12-month
STUDY PROCESS Patients sign the informed consent and should be provided with a signed and dated copy
Interventional process from PCI to discharge The stent implantation process should be consistent with the international standard procedure guideline Other PCI techniques including atherectomy intravascular ultrasound optical interference laminagraphy pressure guide wire technology intra-aortic balloon counterpulsation and so on can be used according to the opinion of the operators
Antiplatelet drugs and anticoagulant therapy is determined by each study center The use of glucoprotein ⅡbⅢa inhibitor and other antiplatelet drugs such as ciloprost is determined by the operators
The standard of instrument success and procedure success
Standard of instrument success After successful convery of RESOLUTE stent system and successful implantation the remaining stenosis rate in diameter less than 50 with TIMI grade 3 without using other interventional techniques
Standard of procedure success With all kinds of interventional therapy the remaining stenosis rate in diameter is less than 20 ocular estimation without occurrence of death myocardial infarction and target lesion revascularization during hospitalization
Post-procedural follow-up After stent implantation each patient will be followed up at time point of 30-day 6-month and 12-month The follow-up includes angina evaluation according to Canadian Cardiovascular Society Classification and Braunwald Classification of unstable angina Glycosylated hemoglobin HbA1c fast glucose level Total Cholesterol LDL level Clinical events including death myocardial infarction ST stroke bleeding and any revascularization
Quantification of angiography QCA All angiographic results of baseline and immediately post-procedure will be sent to the laboratory of SNOC medical technology to do an independent QCA analysis with MEDCON TCS QCA software Reference vessel diameter RVD minimal lumen diameter MLD stent length stenosis percent in diameter and other related data will be reevaluated
ADVERSE EVENT REPORT PROCESS Adverse events supervision committee The Clinical Events Committee CEC is composed of interventional experts who have no relationship with Medtronic and all study centers and they will not directly attend the current study CEC will supervise and determine the events according to the current guidelines as well as the regulations that immobilized to the current study CEC will also do the inspection and determination according to the study endpoints that are based on the systemic analysis of the raw data collection electrocardiogram angiography and so on to ensure a central systemic standardized independent and impartial evaluate process
Definition of adverse events and coping management The adverse events refers to any unacceptable clinical events which may resulted from the instruments Zotarolimus operative procedure or drugs that are necessary for the study for example aspirin or Plavix
Self-consciously reported adverse events are encouraged in the current study Any time during the follow-up patients can inquire the information about likely adverse events directly to the main center If an adverse event is determined all the related information should be collected and related tables should be fulfilled immediately by the researchers
Severe adverse event SAE Severe adverse events refer to death life-threatening disease or injury permanent impairment to body structure or function prolonged hospital stay or hospitalization congenital anomaly is induced and events likely judged by CEC All the severe adverse events should be reported as SAE
Any time SAE occurs regardless of the relationship with the study product proper therapeutic measure should be loading on immediately At the meantime a case report including SAE specific report table should be sent to the main researcher register and supervisor by telephone or email within 24 hours The report to related administration within prescriptive time window should be also carried out in order to assist the inquiry held by the competent department and take proper strategy to redress the protocol and ensure prevention measure
Follow-up duration after adverse events All adverse events should be followed-up and treated until resolved or acquire a stable endpoint
Premature termination of the study case may resulted by the following reasons
1 Patents decision to quit
2 Fail to follow-up a written form mail of verification should be sent to the patient who cant be contacted by telephone If all the communication fails the case should be marked as fail to follow-up
Reasons of quit
It should be encouraged to provide information during follow-up If the patient decide to quit the reason should be recorded immediately Possible reasons may include
1 Patients decision and informed consent retracted
2 Adverse events patients should be followed up until fully recovered or acquire clinically stable
3Fail to follow-up a written form mail of verification should be sent to the patient who cant be contacted by telephone If all the communication fails the case should be marked as fail to follow-up Once there is a chance to confirm patients condition it should also be recorded
Interrupted cases should be included for research analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None