Drug-coating Balloon Treatment in Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DCB treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)
Overview
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
- Device DCB treatment
DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.
Primary outcome measures
- target vessel failure (TVF) at 12 months [Time frame: 12 months]
Secondary outcome measures (3)
- Parameter by quantitative coronary angiography at 7 months [Time frame: 7 months]
- Bleeding at 12 months [Time frame: 12 months]
- Bailout drug-eluting stents (DES) implantation rate [Time frame: During procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT04255563 · KY20200110-03