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

March 24, 2023 updated by: Junjie Zhang, Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
bleeding at 6 months
Time Frame: 6 months
bleeding
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Shao-Liang Chen, MD, Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20200110-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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