Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon (ULTIMATE-III)

Nanjing Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Angiography guidance; Device: IVUS guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT04255043

KY20200110-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

IVUS-guided DCB

Experimental group

Description:

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

Treatment:

Device: IVUS guidance

Angiography-guided DCB

Active Comparator group

Description:

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

Treatment:

Device: Angiography guidance