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Serial Changes After Drug-Coated Balloon

NCT ID: NCT04636931

Last Updated: 2020-11-19

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-01-31

Brief Summary

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The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.

Detailed Description

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Percutaneous coronary intervention with a drug-eluting stent (DES) is the most common mode of revascularization for coronary artery disease. However, their efficacy is limited by in-stent restenosis and stent thrombosis. Drug-coated balloon (DCB) deliver an anti-proliferative drug into the vessel wall and leave nothing behind, which is a promising technique in the treatment of coronary artery disease. Previous many studies have confirmed that DCB treatment for de Novo coronary lesions is safe and efficient. But, data about morphological changes of plaque and factors influencing plaque healing after DCB for de Novo Coronary Lesions is scarce. The study compares morphological changes of plaques evaluated by OCT between baseline and 1-year follow-up and evaluates factors influencing plaque healing. All the included patient will receive dual antiplatelet therapy (DAPT) for one month followed by clopidogrel treatment.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

\- Diagnosed as CAD underwent coronary angiography and OCT Examination.

* Patients with de novo lesion suitable for DCB treatment.
* The reference diameter of targeted artery ≥2.75mm, the length of targeted lesion ≤25mm.
* Agreed to accept DCB treatment and written the informed consent.

Exclusion Criteria

* Patients with de novo lesion unsuitable for DCB treatment.
* In-stent restenosis, coronary dissection, coronary spam, thrombus
* left main artery disease
* Age\>80 years old
* Cardiogenic shock or stroke admission
* Severe hepatic or renal dysfunction
* Poor quality of OCT image or massive thrombus
* Disagreed to accept DCB treatment.
* After pre-dilation of targeted lesions, the patients with residual stenosis\>30%, TIMI flow \<III grade and presence of major dissection (C type or higher).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Da Yin

The director of the cardiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Da Yin, PhD

Role: CONTACT

Phone: 86-0411-83635963-2161

Email: [email protected]

Weili Pan, Phd

Role: CONTACT

Phone: 86-0411-83635963-2161

Email: [email protected]

Facility Contacts

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Da Yin, PhD

Role: primary

Other Identifiers

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HEAL-aDCB

Identifier Type: -

Identifier Source: org_study_id