Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: IVUS guidance
* Device: Angiography guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo lesions, suitable for DCB treatment. Patients with high bleeding risk. Exclusion Criteria: Target lesion length > 15mm. Severe calcified lesions. Left main disease. Ostial lesions. Three-vessel disease. Acute myocardial infarction within 48 hours. Target vessel received stent implantation. Hemodynamic instability.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects will undergo 1:1 randomization to either IVUS or Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS-guided DCB<br>In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up. | Device: IVUS guidance<br>* IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment<br>|
| Active Comparator: Angiography-guided DCB<br>In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography. | Device: Angiography guidance<br>* DCB (Sequent® Please) treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| bleeding at 6 months | bleeding | 6 months |