Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04255043

Acronym

ULTIMATE-III

Enrollment

260

Registered

2020-02-05

Start date

2020-02-03

Completion date

2023-12-30

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEIVUS guidance

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

DEVICEAngiography guidance

DCB (Sequent® Please) treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026