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

Recruiting

• Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Coronary Disease
• Interventions: Device: Synergy XD stent or Synergy Megatron™ Stent

• Registration Number: NCT05044273
• Lead Sponsor: Jung-min Ahn

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-14
• Study Start: 2022-09-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease	Synergy XD stent or Synergy Megatron™ Stent	-

Primary Outcome Measures

Name	Time	Method
The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization	1 year	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.

Secondary Outcome Measures

Name	Time	Method
The event rate of all death	5-year
The event rate of myocardial infarction	5-year
The event rate of target-vessel revascularization	5-year
The composite event rate of death or myocardial infarction	5-year
The composite event rate of cardiac death or myocardial infarction	5-year
The event rate of cardiac death	5-year
The event rate of stent thrombosis	5-year	According to Academic Research Consortium(ARC) criteria
The event rate of procedural success	3 days	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.
The event rate of target-lesion revascularization	5-year
The event rate of stroke	5-year

Trial Locations

Locations (22)

Inje university Pusan Paik hospital; 🇰🇷 Busan, 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

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