Serial Changes After Drug-Coated Balloon

NCT04636931 | Unknown

• 1 other identifier: HEAL-aDCB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major cardiovascular adverse events rate

  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).

  1-year follow-up

Secondary Outcomes (4)

• Differences in lesion characteristics evaluated by OCT between baseline and follow-up.

  1-year follow-up

• Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque.

  1-year follow-up

• The incidence of late lumen loss (LLL) at follow-up.

  1-year follow-up

• Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at follow-up.

  1-year follow-up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CAD patients

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Da Yin, PhD

CONTACT

86-0411-83635963-2161; dlyinda@hotmail.com

Weili Pan, Phd

CONTACT

86-0411-83635963-2161; pwl871103@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the cardiology department

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 19, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)