Coronary Heart DiseaseNCT05133921
The Clinical Efficacy and Safety of Drug-coated Balloon
An observational study of Coronary Heart Disease and Angioplasty, Balloon, run by Xijing Hospital at 1 site in China.
Trial summary
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. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease, Angioplasty, Balloon
- How many people
- 2,487 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 1 Dec 2020
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.
Who may be able to join
- Patients who received PCI with one or more drug-coated balloons (DCB)
- Patients who did not received drug-eluting stent implantation
Who cannot join
- 1. 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: The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study
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. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.
Read more
Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.
Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis<30% post-DCB, maintaining TIMI flow=3, DCB dilation time<60s, and appropriate balloon to vessel ratio> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.
This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.
- Conditions
- Coronary Heart Disease, Angioplasty, Balloon
- Keywords
- Drug-coated balloons, De-novo, All-comers, In-stent stenosis
- Medical subject headings
- Coronary Disease
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 death, target vessel myocardial infraction (TV-MI), and Clinically individual 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 posted24 Nov 2021
- Study start1 Dec 2015
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 2,487 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
- NCT05133921
- Sponsor's protocol ID
- CAGE-FREE registry
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang W, He X, Liu J, Mou F, Liu Y, Yin Z, Li F, Zhou J, Gao H, Hu T, van Geuns RJ, Onuma Y, Serruys PW, Gao C, Tao L. Prognostic Value of Computational Pressure-Flow Dynamics Derived FFR Measured Immediately After Successful Paclitaxel-Coated Balloon Angioplasty for In-Stent Restenosis Lesion. Catheter Cardiovasc Interv. 2026 Aug;108(2):376-387. doi: 10.1002/ccd.70653. Epub 2026 May 17.
PubMed 42144725He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.
PubMed 41174582
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
- The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05133921
- Acronym / sponsor ID
- CAGE-FREE registry
- Conditions
- Coronary Heart Disease, Angioplasty, Balloon
- Keywords
- Drug-coated balloons, De-novo, All-comers, In-stent stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,487 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Nov 2021 (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-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.
Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.
Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.
Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis<30% post-DCB, maintaining TIMI flow=3, DCB dilation time<60s, and appropriate balloon to vessel ratio> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.
This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.
Key inclusion criteria (2 listed)
- Patients who received PCI with one or more drug-coated balloons (DCB)
- Patients who did not received drug-eluting stent implantation
Key exclusion criteria (1 listed)
- 1. 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.
Primary outcome
Device-oriented Composite Endpoint (DoCE)
Time frame: 24 months
DoCE is a composite clinical endpoint of cardiac death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)
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 12 Feb 2026.
- Derived from this study: PubMed 42144725Yang W, He X, Liu J, Mou F, Liu Y, Yin Z, Li F, Zhou J, Gao H, Hu T, van Geuns RJ, Onuma Y, Serruys PW, Gao C, Tao L. Prognostic Value of Computational Pressure-Flow Dynamics Derived FFR Measured Immediately After Successful Paclitaxel-Coated Balloon Angioplasty for In-Stent Restenosis Lesion. Catheter Cardiovasc Interv. 2026 Aug;108(2):376-387. doi: 10.1002/ccd.70653. Epub 2026 May 17.
- Derived from this study: PubMed 41174582He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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 1 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 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?
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?
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?
On the ClinicalTrials.gov record for NCT05133921, which also lists 2 linked publications.
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.