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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Coronary Disease

Keywords

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drug eluting stent percutaneous coronary intervention real world

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease

Synergy XD stent or Synergy Megatron™ Stent

Intervention Type DEVICE

Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Interventions

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Synergy XD stent or Synergy Megatron™ Stent

Percutaneous coronary intervention with Synergy XD stent or Synergy Megatron™ Stent

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jung-min Ahn

Assistant professor of Medicine, Division of Cardiology, Department of Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Coronary Artery Disease

Synergy XD stent or Synergy Megatron™ Stent

Interventions

Synergy XD stent or Synergy Megatron™ Stent

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

CardioVascular Research Foundation, Korea

Jung-min Ahn

Responsible Party

Jung-min Ahn

Locations

Hallym University Medical Center

Dong-A University Hospital

Inje University Busan Paik Hospital

Inje university Pusan Paik hospital

Pusan National University Hospital

Pusan National University Hospital

Pusan National University Yangsan Hospital

Gyeongsang National University Changwon Hospital

Samsung Changwon Hospital

Keimyung University Dongsan Medical Center

Veterans Hospital

Yeungnam University Medical Center

Gangneung Asan Hospital

Chonnam National University Hospital

Wonkwang University Hospital

CHA Bundang Medical Center, CHA University

Seoul university Bundang hospital

Asan Medical Center

Hanyang University Seoul Hospital

Korea University Anam Hospital

Korea University Guro Hospital

The Catholic University of Korea, ST. Vincent's Hospital

Ulsan University Hospital

Countries

Central Contacts

Jung-hee Ham, Project Manager

Facility Contacts

Sang-ho Choi, MD

Yong-rak Cho, MD

Tae-hyun Yang, MD

Jeong-cheon Choi, MD

Min-gu Cheon, MD

Jae-seok Bae, MD

Yong-hwan Park, MD

Chul Hyun Lee, MD

Sang-wook Kang, MD

Woong Kim, MD

Han-bit Park, MD

Min-cheol Kim, MD

Kyung Ho Yoon, MD

Jung-won Suh, MD

Jung-min Ahn, MD

Young-hyo Lim, MD

Jae-hyung Park, MD

Sung-ho Hur, MD

Kyung-min Park, MD

Other Identifiers

AMCCV2021-02