Evaluation of Effectiveness and Safety of Synergy XD and Synergy Megatron™ Stent

Coronary Artery Disease Clinical Trial

— IRIS SynergyXD  

Official title:

Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044273
• Other study ID #: AMCCV2021-02
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Jung-hee Ham, Project Manager
• Phone: 82230104728
• Email: cvcrc5[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents.

Description:

This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stents versus other drug-eluting stents (DES) in patients with coronary artery disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients = 19 years old

• Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s).

• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

• Patients with a mixture of other drug-eluting stents (DESs)

• Terminal illness with life-expectancy =1 year.

• Patients with cardiogenic shock

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• Synergy XD stent or Synergy Megatron™ Stent
Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Pusan National University Yangsan Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Samsung Changwon Hospital	Changwon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Veterans Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	CHA Bundang Medical Center, CHA University	Seongnam
Korea, Republic of	Seoul university Bundang hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Jung-min Ahn	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization	A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.	1 year
Secondary	The event rate of all death		5-year
Secondary	The event rate of cardiac death		5-year
Secondary	The event rate of myocardial infarction		5-year
Secondary	The composite event rate of death or myocardial infarction		5-year
Secondary	The composite event rate of cardiac death or myocardial infarction		5-year
Secondary	The event rate of target-vessel revascularization		5-year
Secondary	The event rate of target-lesion revascularization		5-year
Secondary	The event rate of stent thrombosis	According to Academic Research Consortium(ARC) criteria	5-year
Secondary	The event rate of stroke		5-year
Secondary	The event rate of procedural success	Defined as achievement of final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave myocardial infarction, or urgent revascularization during the index hospitalization.	3 days