Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2023-12-30

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor will remain blinded until the final study results released.

Study Groups

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IVUS-guided DCB

In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.

Group Type EXPERIMENTAL

IVUS guidance

Intervention Type DEVICE

IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment

Angiography-guided DCB

In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.

Group Type ACTIVE_COMPARATOR

Angiography guidance

Intervention Type DEVICE

DCB (Sequent® Please) treatment

Interventions

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IVUS guidance

IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment

Intervention Type DEVICE

Angiography guidance

DCB (Sequent® Please) treatment

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No