Coronary Heart DiseaseNCT05937230
Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients
An observational study of Coronary Heart Disease and Angioplasty, Balloon, run by Xijing Hospital at 1 site in China.
Trial summary
Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Angioplasty, Balloon
- What is being tested?
- Drug-coated balloon and Drug-eluting stents
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2015to 1 Mar 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All diabetic patients who received PCI with one or more drug-coated balloons only or drug-eluting stents only to treat ISR or de novo lesions
Who may be able to join
- Patients with diabetes mellitus
- Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy
Who cannot join
- Under the age of 18
- Unable to give informed consent
- Currently participating in another trial or participants unable to comply to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Performance of Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients: a Real-world, Prospective Study
Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon.
DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained.
Read more
Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.
- Conditions
- Coronary Heart Disease, Angioplasty, Balloon
- Being tested
- Drug-coated balloon, Drug-eluting stents
- Keywords
- Drug-eluting stents, Drug-coated balloons, Diabetic, De-novo, In-stent stenosis, All-comers
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloonDevice
Paclitaxel is a pharmacologically active substance for anti-neointima.
Drug-eluting stentsDevice
Drug-eluting stent is composed of a metal stent, primer, and drug coating.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Paclitaxel coated balloon Receives: Device: Drug-coated balloon | |
| Drug-eluting stent | Second-generation eluting stents Receives: Device: Drug-eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-oriented Composite Endpoint (DoCE)
DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Jun 2015
- Primary completion1 Mar 2023
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Tao, MD, PhD, Xijing Hospital
- Investigators
- Ling Tao, MD, Ph.D., Study chair, Xijing HospitalChao Gao, MD, Ph.D., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937230
- Sponsor's protocol ID
- CAGE-FREE DM registry
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2023
- Last updated
- 12 Feb 2026
- Results posted
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Performance of Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients: a Real-world, Prospective Study
- ClinicalTrials.gov ID
- NCT05937230
- Acronym / sponsor ID
- CAGE-FREE DM registry
- Conditions
- Coronary Heart Disease, Angioplasty, Balloon
- Keywords
- Drug-eluting stents, Drug-coated balloons, Diabetic, De-novo, In-stent stenosis, All-comers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Jul 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.
Drug-eluting stents (DES) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (PCI). Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon.
DCB angioplasty has the following advantages compared to DES implantation: Firstly, the drug in DCB is uniformly distributed and released, whereas the drug release of DES via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly, there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, and the physiological function of coronary arteries would be maintained.
Currently, DCB constitutes an important treatment option in ISR, which is endorsed by the 2018 European Society of Cardiology Guidelines on myocardial revascularization. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB is non-inferior to the drug-eluting stent (DES), there is still a lack of evidence comparing the DCB versus DES for de novo or ISR coronary lesions in diabetic patients. The current study aims to compare the long-term efficacy of DCB to DES in de novo or ISR coronary lesions in diabetic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | – | Device: Drug-coated balloonPaclitaxel coated balloon |
| Drug-eluting stent | – | Device: Drug-eluting stentsSecond-generation eluting stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All diabetic patients who received PCI with one or more drug-coated balloons only or drug-eluting stents only to treat ISR or de novo lesions
Key inclusion criteria (2 listed)
- Patients with diabetes mellitus
- Received PCI by a drug-coated balloons only strategy or drug-eluting stents only strategy
Key exclusion criteria (3 listed)
- Under the age of 18
- Unable to give informed consent
- Currently participating in another trial or participants unable to comply to follow-up
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 |
|---|---|---|
| Drug-coated balloonPaclitaxel is a pharmacologically active substance for anti-neointima. | Device | Drug-coated balloon |
| Drug-eluting stentsDrug-eluting stent is composed of a metal stent, primer, and drug coating. | Device | Drug-eluting stent |
Primary outcome
Device-oriented Composite Endpoint (DoCE)
Time frame: 24 months
DoCE is a composite clinical endpoint of Cardiac cause death, Target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 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.
Ling Tao, MD, Ph.D. study chair
Xijing Hospital
Chao Gao, MD, Ph.D. study chair
Xijing Hospital
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 Heart Disease and Angioplasty, Balloon, run by Xijing Hospital 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Device-oriented Composite Endpoint (DoCE) (time frame: 24 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 12 Feb 2026.