coronary intervention
Devicebioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
NCT Number: NCT02316886
The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Kyoto University Hospital, Kyoto, Japan
Sub-analysis for each imaging test will be performed as below;
Extended follow-up:
Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
Time frame: 2 years
target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Periprocedural or spontaneous, target-vessel or non-target-vessel related
Time frame: 2 years
Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)
Time frame: 2 years
Time frame: 2 years
cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
Time frame: 2 years
defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina
Time frame: 2 years
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
life-threatening or disabling, major or minor
Time frame: 2 years
Time frame: 2 years
It is assessed by the Canadian Cardiovascular Society (CCS) Classification at each point in time.
The Canadian Cardiovascular Society (CCS) classification has four categories; the minimum and maximum values are 1 and 4 respectively. A higher score means a worse outcome.
Time frame: 2 years
Number of anti-anginal medication at each point in time
Seung-Jung Park
Other
a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial
Acronym: PREVENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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