Coronary Artery DiseaseNCT05750771
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
A study testing DES and DCB in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- DES and DCB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 1 Aug 2025
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. older than 60 years of age.
- 2. meeting the indications for coronary intervention.
- 3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) ;
- 4. Target lesion vessel diameter > 2.75 mm
Who cannot join
- 1. inability to provide written informed consent.
- 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
- 3. the subject is participating in another uncompleted clinical trial
- 4. life expectancy <1 year.
- 5. non-in situ vascular lesions.
- 6. cardiogenic shock.
- 7. Patients with hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.
And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
- Conditions
- Coronary Artery Disease
- Being tested
- DES, DCB
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESDevice
Second-generation drug-eluting stents
DCBDevice
Drug-coated balloon with paclitaxel as drug coating
| Study group | Role | What they receive |
|---|---|---|
| DCB Group | Experimental | Implantation of drug-coated balloons in patients with satisfactory pretreatment Receives: Device: DCB |
| DES Group | Experimental | Implantation of drug-eluting stents in patients with satisfactory pretreatment Receives: Device: DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
LLL
Late lumen loss (LLL) of the target lesion segment
Measured: 12 months
Secondary outcomes (1)
MACE
Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction
Measured: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Feb 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, MD, Study chair, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750771
- Sponsor's protocol ID
- HenanICE202303
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05750771
- Acronym / sponsor ID
- HenanICE202303
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 2 Mar 2023 (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 goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.
And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB Group | Experimental | Device: DCBImplantation of drug-coated balloons in patients with satisfactory pretreatment |
| DES Group | Experimental | Device: DESImplantation of drug-eluting stents in patients with satisfactory pretreatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. older than 60 years of age.
- 2. meeting the indications for coronary intervention.
- 3. IVUS examination suggests severe calcified lesions (calcification angle > 270° at the target lesion) ;
- 4. Target lesion vessel diameter > 2.75 mm
Key exclusion criteria (7 listed)
- 1. inability to provide written informed consent.
- 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
- 3. the subject is participating in another uncompleted clinical trial
- 4. life expectancy <1 year.
- 5. non-in situ vascular lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESSecond-generation drug-eluting stents | Device | DES Group |
| DCBDrug-coated balloon with paclitaxel as drug coating | Device | DCB Group |
Primary outcome
LLL
Time frame: 12 months
Late lumen loss (LLL) of the target lesion segment
1 secondary outcome
MACE
Time frame: Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
Muwei Li, MD study chair
Fuwai central China cardiovascular hospotial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DES and DCB in people with Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology 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 7 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: finished, as of the sponsor's last update on 6 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LLL (time frame: 12 months). 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 6 Apr 2026.