Treatment for coronary artery disease using drug-coated balloons
Official title: Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
Run by Nanjing First Hospital, Nanjing Medical University · NCT04255563 · Data updated 2026-11-12
This study is testing how well drug-coated balloons work for treating people with coronary artery disease and checking if they are safe to use.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | February 25, 2020 |
| Main results expected | December 30, 2030 |
| Study ends | December 30, 2030 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT04255563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with coronary artery disease who are suitable for drug-coated balloon treatment.
✕Probably not a fit
Patients who are pregnant, have contraindications to contrast media or antiplatelet therapy, or are in cardiac shock may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the efficacy and safety of drug-coated balloon (DCB) treatment in patients with coronary artery disease (CAD). It is a prospective, multi-center registry that enrolls patients undergoing DCB treatment without strict inclusion and exclusion criteria. Data and images will be collected during the procedure and at follow-up visits to assess outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for managing coronary artery disease, potentially improving patient outcomes.
How similar studies have gone: Other studies have shown promising results with drug-coated balloon treatments in similar patient populations, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients suitable for DCB treatment Exclusion Criteria: * Pregnancy * Contraindications to contrast media, antiplatelet therapy, or paclitaxel * Expected life less than 12 months * Cardiac shock
Where it's running
-
Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Jun-Jie Zhang, MD
- Email: jameszll@163.com
- Phone: 025-52271350
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.