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Serial Changes After Drug-Coated Balloon (HEAL-aDCB)

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ClinicalTrials.gov Identifier: NCT04636931
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Da Yin, The First Affiliated Hospital of Dalian Medical University

Study Description
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Brief Summary:
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.

Condition or disease
Coronary Artery Disease

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Morphological Changes of Plaque and Factors Influencing Plaque Healing After Drug-Coated Balloon for de Novo Coronary Lesions: A Optical Coherence Tomography Study
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Major cardiovascular adverse events rate [ Time Frame: 1-year follow-up ]
    In patients treated by DCB, the safety objectives are to evaluate the occurrence of any adverse events in 1 year (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).


Secondary Outcome Measures :
  1. Differences in lesion characteristics evaluated by OCT between baseline and follow-up. [ Time Frame: 1-year follow-up ]
    Lesion characteristics evaluated by OCT include lipid-rich plaque, fibrous plaque, macrophage, cholesterol crystal, microchannels and calcification and minimal lumen area (MLA). The follow-up OCT assessment will be performed 12 months after the treatment procedure.

  2. Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque. [ Time Frame: 1-year follow-up ]
    The characteristics of lipid-plaque evaluated by OCT include lipid core length, mean lipid arc, max lipid arc, fibrous cap thickness (FCT). The follow-up OCT assessment will be performed 12 months after the treatment procedure.

  3. The incidence of late lumen loss (LLL) at follow-up. [ Time Frame: 1-year follow-up ]
    LLL is defined as MLA at follow-up - MLA at baseline < 0.

  4. Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at follow-up. [ Time Frame: 1-year follow-up ]
    All the patients are divided into two groups according to presence of late lumen loss (LLL) at follow-up. The OCT-defined characteristics include plaque rupture, plaque erosion, lipid-rich plaque, fibrous plaque, macrophage, cholesterol crystal, microchannels and calcification. If the plaque is rich in lipid, the lipid core length, mean lipid arc, max lipid arc, fibrous cap thickness (FCT) will be compared.


Biospecimen Retention:   Samples With DNA
Blood samples (5 ml) were collected before intervention using EDTA tubes at baseline and follow-up. Plasma samples were separated by centrifugation at 1000 g for 10 min and then stored at -80 °C until further analysis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CAD patients
Criteria

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.
  • Life expectancy < 1year. Angiographic Exclusion Criteria
  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636931


Contacts
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Contact: Da Yin, PhD 86-0411-83635963-2161 dlyinda@hotmail.com
Contact: Weili Pan, Phd 86-0411-83635963-2161 pwl871103@126.com

Locations
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China, Liaoning
First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China
Contact: Da Yin, PhD    86-0411-83635963-2161    dlyinda@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
More Information
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Responsible Party: Da Yin, The director of the cardiology department, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT04636931    
Other Study ID Numbers: HEAL-aDCB
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases