A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02796157|
Recruitment Status : Unknown
Verified May 2018 by Yonsei University.
Recruitment status was: Recruiting
First Posted : June 10, 2016
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold Device: PCI with Xience everolimus-eluting metallic stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Active Comparator: absorb arm
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.
Experimental: Xience arm
PCI with Xience everolimus-eluting metallic stent
Device: PCI with Xience everolimus-eluting metallic stent
Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.
- Incidence of composite of major adverse cardiovascular events [ Time Frame: 1 year after PCI ]Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796157
|Korea, Republic of|
|Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: MYEONG-KI HONG, MD 82-2-2228-8458 MKHONG61@yuhs.ac|