NCT04255043Completed
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 20 Jan 2020
- Start date
- 3 Feb 2020
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT04255043
What you commit to
- Study type: Interventional
- Participants enrolled: 260
- From 3 Feb 2020 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Target vessel received stent implantation.
Other illness
- Left main disease.
- Three-vessel disease.
- Acute myocardial infarction within 48 hours.
Other
- Target lesion length \> 15mm.
- Severe calcified lesions.
- Ostial lesions.
- Hemodynamic instability.
Who the study is looking for
- De novo lesions, suitable for DCB treatment.
- Patients with high bleeding risk.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.