A Phase 4 interventional study of Cypher, xience, Endeavor, Taxus and optimal medical therapy in Coronary Artery Disease, sponsored by Seung-Jung Park. Terminated at 26 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Seung-Jung Park · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.
Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year.
The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.
The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 840 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinical
Angiographic
CTO definition: TIMI flow 0 and estimated duration over 3 months The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion
Exclusion Criteria:
optimal medical therapy
Drug: optimal medical therapy
Cypher, xience, Endeavor, Taxus
Procedure: Cypher, xience, Endeavor, Taxus
all species of drug-eluting stent implantation
Also known as: percutaneous coronary intervention
optimal medical therapy
Also known as: intensive medical therapy
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
at the median of 3 years
Time frame: at 3 years
All Death (Cardiac death)
Time frame: at 3 years & 5 years
Angina class; Quality of life, clinical outcomes at 5 years
Time frame: at 3 years & 5 years
Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction
Time frame: at 3 years & 5 years
Plan to share: No — This is not a publicly funded trial.
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Seung-Jung Park