Drug-coating Balloon Treatment in Coronary Artery Disease (ULTIMATE-DCB)

June 26, 2022 updated by: Junjie Zhang, Nanjing First Hospital, Nanjing Medical University

Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)

Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Study Type

Observational

Enrollment (Anticipated)

3000

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

Sampling Method

Non-Probability Sample

Study Population

All subjects with coronary artery disease undergoing DCB treatment will be enrolled in this study.

Description

Inclusion Criteria:

  • Patients suitable for DCB treatment

Exclusion Criteria:

  • Pregnancy
  • Contraindications to contrast media, antiplatelet therapy, or paclitaxel
  • Expected life less than 12 months
  • Cardiac shock

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DCB treatment
DCB (Sequent® Please) treatment will be performed for suitable patients with CAD.
Device: DCB treatment
DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target vessel failure (TVF) at 12 months
Time Frame: 12 months
TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameter by quantitative coronary angiography at 7 months
Time Frame: 7 months
Late lumen loss
7 months
Bleeding at 12 months
Time Frame: 12 months
bleeding
12 months
Bailout drug-eluting stents (DES) implantation rate
Time Frame: During procedure
Bailout DES implantation rate during procedure by angiographic criteria
During procedure

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 25, 2020

Primary Completion (Anticipated)

December 30, 2030

Study Completion (Anticipated)

December 30, 2030

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)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20200110-03

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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