Coronary Artery DiseaseHEAL-aDCBNCT04636931
Serial Changes After Drug-Coated Balloon
An observational study of Coronary Artery Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CAD patients
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Da Yin, PhD, 86-0411-83635963-2161, dlyinda@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-year follow-up
Secondary outcomes (4)
Differences in lesion characteristics evaluated by OCT between baseline and 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.
Measured: 1-year follow-up
Differences in lipid-plaque characteristics evaluated by OCT between baseline and follow-up in setting of lipid-plaque.
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.
Measured: 1-year follow-up
The incidence of late lumen loss (LLL) at follow-up.
LLL is defined as MLA at follow-up - MLA at baseline < 0.
Measured: 1-year follow-up
Differences in OCT-defined characteristics at baseline according to the presence of late lumen loss (LLL) at 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.
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Da Yin, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636931
- Sponsor's protocol ID
- HEAL-aDCB
- Acronym
- HEAL-aDCB
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04636931
- Acronym / sponsor ID
- HEAL-aDCB / HEAL-aDCB
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CAD patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Differences in lesion characteristics evaluated by OCT between baseline and follow-up.
Time frame: 1-year follow-up
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 incidence of late lumen loss (LLL) at follow-up.
Time frame: 1-year follow-up
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Da Yin, PhD (86-0411-83635963-2161, dlyinda@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular adverse events rate (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.