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OpenTrials
Completed

NCT Number: NCT04255043

Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVUS guidance

Device

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

Angiography guidance

Device

DCB (Sequent® Please) treatment

Primary outcomes

  1. late lumen loss (LLL) at 7 months after procedure

    Time frame: 7 months

    LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up

Secondary outcomes

  1. Target vessel failure (TVF) at 6 months

    Time frame: 6 months

    TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.

  2. bleeding at 6 months

    Time frame: 6 months

    bleeding

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: ULTIMATE-III

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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