Coronary Artery Disease
Conditions
Brief summary
Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.
Detailed description
This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment. All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.
Interventions
DEVICEDCB treatment
DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target vessel failure (TVF) at 12 months | 12 months | TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameter by quantitative coronary angiography at 7 months | 7 months | Late lumen loss |
| Bleeding at 12 months | 12 months | bleeding |
| Bailout drug-eluting stents (DES) implantation rate | During procedure | Bailout DES implantation rate during procedure by angiographic criteria |
Countries
China
Contacts
Primary ContactJun-Jie Zhang, MD
Backup ContactXiao-Fei Gao, MD
Outcome results
None listed