PCIDTNCT07764094
Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease
An observational study of PCI and Drug-coated Balloon, run by Nanjing First Hospital, Nanjing Medical University at 7 sites in China.
Trial summary
This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PCI, Drug-coated Balloon, Coronary Artery Disease
- How many people
- 500 participants
- Where
- 7 sitesChina
- Study dates
- 1 Sep 2026to 30 Jun 2028
- How long will I take part?
- 1 Year
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI
Who may be able to join
- Age ≥18 years
- Stable coronary artery disease or unstable angina
- De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
- Planned DCB strategy for PCI
- Written informed consent
Who cannot join
- Acute myocardial infarction within 72 hours
- Severe heart failure (NYHA class IV)
- Severe hepatic or renal insufficiency
- Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
- Life expectancy <12 months
- Pregnancy or breastfeeding
Show all 10Show fewer
- Concurrent participation in another clinical trial
- In-stent restenosis
- Unsuccessful recanalization of main vessel or side branch chronic total occlusion
- Hemodynamic instability
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tian-lei Zhang, MD contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Chuzhou First People's Hospital
Chuzhou, Anhui, 239000
Feng Li, MD, 18905502878 ext. +86, xnklifeng@163.com
- Recruiting
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223000
Nai-quan Yang, MD, 13605235756 ext. +86, qnyang2005@163.com
- Recruiting
Lianyungang First People's Hospital
Lianyungang, Jiangsu, 222000
De-lu Yin, MD, 18961326475 ext. +86, druseyin@163.com
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Fei Ye, MD, 18951670287 ext. +86, doctor_ye@126.com
- Recruiting
Tongling People's Hospital
Tongling, Anhui, 244000
Lu Ye, MD, 13856203562 ext. +86, tlyelu1682@163.com
- Recruiting
Xuzhou Second People's Hospital
Xuzhou, Jiangsu, 221000
De-feng Pan, MD, 18052068281 ext. +86, xzdefengpan@xzhmu.edu.cn
- Recruiting
Yixing People's Hospital
Yixing, Jiangsu, 214200
Liang Xu, MD, 18861576565 ext. +86, xl97010222@163.com
About this study
Official title: Impact of Drug-Coated Balloon Procedural Factors on Angiographic and Clinical Outcomes of Percutaneous Coronary Intervention for De Novo Lesions: A Multicenter, Prospective, Observational Registry
This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.
Read the detailed description
This study aimed to systematically investigate drug-coated balloon procedural factors including Y-to-B delivery time, inflation duration among patients with de novo coronary lesions undergoing PCI.The impact of these procedural factors on angiographic and clinical outcomes will be analyzed.Based on these findings, novel techniques and pretreatment strategies may be proposed to optimize the DCB treatment process
- Conditions
- PCI, Drug-coated Balloon, Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Drug coated balloon
- 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.
| Study group | Role | What they receive |
|---|---|---|
| DCB-Treated De Novo Lesion | Patients undergoing drug-coated balloon treatment for de novo coronary lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Target Lesion Restenosis
Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up
Measured: 6-12 months
Secondary outcomes (1)
Number of Participants with Target Vessel Failure
Composite of cardiac death, target-vessel myocardial infarction (TVMI), and clinically driven target-vessel revascularization(TVR)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PCIStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye-fei, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764094
- Sponsor's protocol ID
- KY20260528-01
- Acronym
- DT
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
Publications
Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
PubMed 39236727Kiyohara Y, Aikawa T, Saito T, Casso Dominguez A, Wiley J, Kolte D, Secemsky EA, Yeh RW, Laham RJ, Latib A, Bhatt DL, Kuno T. Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon Angioplasty: A Network Meta-Analysis of Randomized Controlled Trials. Circ Cardiovasc Interv. 2026 Jan;19(1):e016005. doi: 10.1161/CIRCINTERVENTIONS.125.016005. Epub 2025 Oct 27.
PubMed 41145110Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.
PubMed 39714903
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Drug-Coated Balloon Procedural Factors on Angiographic and Clinical Outcomes of Percutaneous Coronary Intervention for De Novo Lesions: A Multicenter, Prospective, Observational Registry
- ClinicalTrials.gov ID
- NCT07764094
- Acronym / sponsor ID
- DT / KY20260528-01
- Conditions
- PCI, Drug-coated Balloon, Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Drug coated balloon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Aug 2026 (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.
This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.
Detailed description
This study aimed to systematically investigate drug-coated balloon procedural factors including Y-to-B delivery time, inflation duration among patients with de novo coronary lesions undergoing PCI.The impact of these procedural factors on angiographic and clinical outcomes will be analyzed.Based on these findings, novel techniques and pretreatment strategies may be proposed to optimize the DCB treatment process
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB-Treated De Novo Lesion | – | –Patients undergoing drug-coated balloon treatment for de novo coronary lesions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI
Key inclusion criteria (5 listed)
- Age ≥18 years
- Stable coronary artery disease or unstable angina
- De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
- Planned DCB strategy for PCI
- Written informed consent
Key exclusion criteria (10 listed)
- Acute myocardial infarction within 72 hours
- Severe heart failure (NYHA class IV)
- Severe hepatic or renal insufficiency
- Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
- Life expectancy <12 months
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
Number of Participants with Target Lesion Restenosis
Time frame: 6-12 months
Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up
1 secondary outcome
Number of Participants with Target Vessel Failure
Time frame: 6-12 months
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 28 Aug 2026.
- Background: PubMed 39236727Gao C, He X, Ouyang F, Zhang Z, Shen G, Wu M, Yang P, Ma L, Yang F, Ji Z, Wang H, Wu Y, Fang Z, Jiang H, Wen S, Liu Y, Li F, Zhou J, Zhu B, Liu Y, Zhang R, Zhang T, Wang P, Liu J, Jiang Z, Xia J, van Geuns RJ, Capodanno D, Garg S, Onuma Y, Wang D, Serruys PW, Tao L; REC-CAGEFREE I Investigators. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial. Lancet. 2024 Sep 14;404(10457):1040-1050. doi: 10.1016/S0140-6736(24)01594-0. Epub 2024 Sep 2.
- Background: PubMed 41145110Kiyohara Y, Aikawa T, Saito T, Casso Dominguez A, Wiley J, Kolte D, Secemsky EA, Yeh RW, Laham RJ, Latib A, Bhatt DL, Kuno T. Comparison of Limus and Paclitaxel Drug-Coated Balloons, Second-Generation or Newer Drug-Eluting Stents, and Balloon Angioplasty: A Network Meta-Analysis of Randomized Controlled Trials. Circ Cardiovasc Interv. 2026 Jan;19(1):e016005. doi: 10.1161/CIRCINTERVENTIONS.125.016005. Epub 2025 Oct 27.
- Background: PubMed 39714903Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.
- Individual participant dataSharing planned: No. Due to privacy and ethical limitations, the data generated and analyzed in current study are not publicly available but could be obtained from principal investigator upon the approval of ethics committee
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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.
Tian-lei Zhang, MD contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCI and Drug-coated Balloon, run by Nanjing First Hospital, Nanjing Medical University at 7 sites 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 5 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Contact Fei Ye, MD (18951670287 ext. +86, doctor_ye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Target Lesion Restenosis (time frame: 6-12 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 NCT07764094, which also lists 3 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 28 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.