Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSeung-Whan Lee, M.D., Ph.D.

About this trial

Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged>=19

Patients who have a CTO lesion in at least one or more epicardial coronary artery 2.5 mm in blood vessel diameter

Patients who have symptoms of angina or objectively proven myocardial ischemia (asymptomatic myocardial ischemia, stable or unstable angina, non - -ST-segment elevation myocardial infarction)

Patients who voluntarily agreed to the protocol and the clinical follow-up plan (or let their representative do this), and signed the informed consent form approved by the IRB of each study institute

Disqualifiers

Patients who are pregnant or lactating or have childbearing potential Patients in whom contrast medium and heparin are contraindicated or who are hypersensitive to them

Patients in whom aspirin, clopidogrel, ticagrelor and prasugrel, cilostazol are contraindicated

Patients scheduled to undergo a surgery, etc. that requires discontinuance of an antiplatelet drug within 12 months after participation in the study

Acute ST elevation myocardial infarction at the time of hospitalization

Trial population

Subject selection will be determined after screening patients who undergo PCI for CTO lesions and completing the evaluation of all inclusion/exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • antegrade and retrograde approach

    Procedure/Surgery

    This study intends to identify and compare the clinical, anatomical and periprocedural factors of the patients who used only the antergrade approach and the patients who needed the retrograde approach among the patients with coronary CTO

Treatment groups

4,000 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

Death

Death

Time frame
12-month after PCI
2

myocardial infarction

the periprocedural myocardial infarction under the SCAI definition or the non-lethal myocardial infarction during the follow-up observations

Time frame
12-month after PCI
3

the complex endpoints of target vessel revascularization/reocclusion occurrence

including chronic total occlusion and angiostenosis

Time frame
12-month after PCI

Secondary outcomes

1

Procedure success rate

A procedure success defined as the case where a final vessel diameter stenosis \< 30% is achieved after the stent insertion

Time frame
every 1-year up-to 5-year
2

Myocardial infarction

Q-wave VS non-Q-wave, periprocedural myocardial infarction VS follow-up myocardial infarction (spontaneous myocardial infarction

Time frame
every 1-year up-to 5-year

Other outcomes

Sponsors and contacts

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

Seung-Whan Lee, M.D., Ph.D.

Lead sponsor

Asan Medical Center

Sponsor institution

Abbott Medical Devices

Collaborator

Teleflex

Collaborator

Medtronic

Collaborator

Dio

Collaborator