ClinicalTrials.gg
RecruitingNCT07764094DTUpdated Aug 28, 2026

Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease

An observational study in PCI, Drug-coated Balloon and Coronary Artery Disease, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Coronary Artery Disease by Nanjing First Hospital, Nanjing Medical University — 7 open to participants now, 11 under way, none of them phase 3. Coronary Artery Disease · Nanjing First Hospital, Nanjing Medical University.

Started
2026
with 4 others
Observational
5 of 19
3 open now
Primary completion
2027-12
later than 6 of 10 live
Registered
18th of 19
by date

Among the 19 studies in Coronary Artery Disease by Nanjing First Hospital, Nanjing Medical University, this one is one of 5 that started in 2026, is one of 5 observational ones, reaches primary completion later than 6 of the 10 other live ones, and was the 18th registered.

Coronary Artery Disease

4,861 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

7 of the 19 studies in Coronary Artery Disease by Nanjing First Hospital, Nanjing Medical University are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Coronary Artery Disease by Nanjing First Hospital, Nanjing Medical University, or all of them as a file.
02

Study 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 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

03

Conditions studied

  • PCI
  • Drug-coated Balloon
  • Coronary Artery Disease

Keywords

  • Percutaneous coronary intervention
  • Drug coated balloon
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years
  2. Stable coronary artery disease or unstable angina
  3. De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
  4. Planned DCB strategy for PCI
  5. Written

Exclusion criteria

Exclusion Criteria:

  1. Acute myocardial infarction within 72 hours
  2. Severe heart failure ( class IV)
  3. Severe hepatic or renal insufficiency
  4. Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
  5. \<12 months
  6. Pregnancy or breastfeeding
  7. Concurrent participation in another clinical trial
  8. In-stent restenosis
  9. Unsuccessful recanalization of main vessel or side branch chronic total occlusion
  10. Hemodynamic instability
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • DCB-Treated De Novo Lesion

    Patients undergoing drug-coated balloon treatment for de novo coronary lesions

06

What researchers measure

Primary outcomes

  1. Number of Participants with Target Lesion Restenosis

    Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up

    Time frame: 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)

    Time frame: 6-12 months

07

Study locations

7 of 7 sites recruiting
08

References and documents

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 39236727 ↗
  • Kiyohara 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 41145110 ↗
  • Camaj 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 ↗

Individual participant data

Plan to share: 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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.

Of 636 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 15 months is below that.

Counting every sponsor, half of 761 studies reached it within 41 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 13, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07764094
Responsible party
Ye-fei (chief physician, Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Fei Ye, MD
Contact
doctor_ye@126.com
18951670287 ext. +86
Tian-lei Zhang, MD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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