Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Coronary Artery Disease Clinical Trial

— ULTIMATE-III  

Official title:

Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon Treatment for Denovo Lesions in High Bleeding Risk Patients: a Prospective, Multi-center, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255043
• Other study ID #: KY20200110-02
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• 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: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective, multicenter, randomized controlled trial that aims to enroll 260 patients with high bleeding risk.

All patients with coronary denovo lesions suitable for DCB treatment will undergo 1:1 randomization to either IVUS guidance or Angiography guidance using the Central Randomization System.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol. Data and images will be collected during the index procedure, and at the predefined 7-month coronary angiography follow-up visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. De novo lesions, suitable for DCB treatment.

2. Patients with high bleeding risk.

Exclusion Criteria:

1. Target lesion length > 15mm.

2. Severe calcified lesions.

3. Left main disease.

4. Ostial lesions.

5. Three-vessel disease.

6. Acute myocardial infarction within 48 hours.

7. Target vessel received stent implantation.

8. Hemodynamic instability.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• IVUS guidance
IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
• Angiography guidance
DCB (Sequent® Please) treatment

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	late lumen loss (LLL) at 7 months after procedure	LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up	7 months
Secondary	Target vessel failure (TVF) at 6 months	TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.	6 months
Secondary	bleeding at 6 months	bleeding	6 months