Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: IVUS guidance; Device: Angiography guidance

• Registration Number: NCT04255043
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-02
• Study Start: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVUS-guided DCB	IVUS guidance	In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.
Angiography-guided DCB	Angiography guidance	In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.

Primary Outcome Measures

Name	Time	Method
late lumen loss (LLL) at 7 months after procedure	7 months	LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
Target vessel failure (TVF) at 6 months	6 months	TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.
bleeding at 6 months	6 months	bleeding

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China