Drug-coating Balloon Treatment in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— ULTIMATE-DCB  

Official title:

Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255563
• Other study ID #: KY20200110-03
• Status: Recruiting
• Start date: February 25, 2020
• Est. completion date: December 30, 2030

Study information

• Verified date: June 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jun-Jie Zhang, MD
• Phone: 025-52271350
• Email: jameszll[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2030
• Est. primary completion date: December 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DCB treatment
DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target vessel failure (TVF) at 12 months	TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.	12 months
Secondary	Parameter by quantitative coronary angiography at 7 months	Late lumen loss	7 months
Secondary	Bleeding at 12 months	bleeding	12 months
Secondary	Bailout drug-eluting stents (DES) implantation rate	Bailout DES implantation rate during procedure by angiographic criteria	During procedure