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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IVUS guidance
Angiography guidance
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVUS-guided DCB

Angiography-guided DCB

Arm Description

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

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

Outcomes

Primary Outcome Measures

late lumen loss (LLL) at 7 months after procedure
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up

Secondary Outcome Measures

Target vessel failure (TVF) at 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
bleeding

Full Information

First Posted
January 20, 2020
Last Updated
March 24, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04255043
Brief Title
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
Acronym
ULTIMATE-III
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will remain blinded until the final study results released.
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVUS-guided DCB
Arm Type
Experimental
Arm Description
In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.
Arm Title
Angiography-guided DCB
Arm Type
Active Comparator
Arm Description
In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.
Intervention Type
Device
Intervention Name(s)
IVUS guidance
Intervention Description
IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
Intervention Type
Device
Intervention Name(s)
Angiography guidance
Intervention Description
DCB (Sequent® Please) treatment
Primary Outcome Measure Information:
Title
late lumen loss (LLL) at 7 months after procedure
Description
LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Target vessel failure (TVF) at 6 months
Description
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization.
Time Frame
6 months
Title
bleeding at 6 months
Description
bleeding
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Jie Zhang, MD
Phone
025-52271350
Email
jameszll@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Fei Gao, MD
Phone
025-52271350
Email
gaoxiaofei2014@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoliang Chen, MD
Phone
13605157029
Email
chmengx@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

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