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The DECISION-CTO Extended 10 Y Follow-up

ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeung-Jung Park

About this trial

The goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years

Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) At least one CTO lesions located in proximal or mid epicardial coronary artery.

CTO definition: TIMI (Thrombolysis in Myocardial Infarction) flow 0 or 1 with estimated duration over 3 months

The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or

Disqualifiers

History of bleeding diathesis or coagulopathy

Pregnant state

Three vessel CTOs

Known hypersensitivity or contra-indication to contrast agent and heparin

Trial population

Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

840 Participants
are grouped into 1 trial group
Group A: Patients with chronic total occlusion

Trial outcomes

Primary outcomes

1

Event rate of the composite event

The composite of all cause death, myocardial infarction, stroke and any revascularization at minimum of 10 years follow-up.

Time frame
10 years

Secondary outcomes

1

Event rate of all cause death

Time frame
10 years
2

Event rate of myocardial infarction

Time frame
10 years
3

Event rate of stroke

Time frame
10 years
4

Event rate of any revascularization

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seung-Jung Park

Lead sponsor

Asan Medical Center

Sponsor institution

Source ClinicalTrials.gov
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