Treatment for coronary artery disease using drug-coated balloons
Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04255563 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with coronary artery disease who are suitable for drug-coated balloon treatment.
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.
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 performed: Other studies have shown promising results with drug-coated balloon treatments in similar patient populations, indicating potential for success.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Jun-Jie Zhang, MD
- Email: jameszll@163.com
- Phone: 025-52271350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.