CTO Registry From Insight of IVUS in Fuwai Hospital

NCT ID: NCT03461367

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-31

Brief Summary

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To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent contemporary percutaneous coronary intervention (PCI) techniques, we design this single-center, large-sample, prospective registry with five-year clinical follow-up, based on the intravascular ultrasound (IVUS) finding.

Detailed Description

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The study plan to include the patients with a CTO lesion in one of the three main epicardial coronary artery (diameter more than 2.5 mm) as the only target lesion. The CTO lesion is defined as 0 grade of thrombolysis in myocardial infarction (TIMI) flow with evidence of occlusion duration more than 3 months. All the PCI procedure will be performed by a group of certified operators in Fuwai Hospital, Beijing, China. All patients evaluate IVUS with automatic pullback (Opticross, Boston Scientific, US) performed after wire crossing. All the included patients are planned for five-year follow-up.

Conditions

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Coronary Heart Disease Chronic Total Occlusion of Coronary Artery Percutaneous Coronary Intervention Intravascular Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female patient \>18 years old
* Thrombolysis in myocardial infarction trial (TIMI) 0 grade.
* Evidence of occlusion period more than 3 months.
* Patients eligible for PCI.
* Patients eligible for coronary artery bypass graft (CABG).
* Target vessel is one of the three main epicardial coronary arteries.

Exclusion Criteria

* Acute myocardial infarction with ongoing ST-elevation
* Target vessel is left main or graft vessel.
* Target vessel diameter \< 2.5 mm.
* Other situations ineligible for PCI judged in clinical practice.
* Left ventricular ejection fraction \<30%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lei Song, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Xu

Role: STUDY_DIRECTOR

Fuwai Hospital, Catheter Lab

Locations

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Lei Song

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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20180223

Identifier Type: -

Identifier Source: org_study_id

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