Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

August 12, 2024 updated by: Eun-Seok Shin, Ulsan Medical Center
This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.

Study Type

Observational

Enrollment (Estimated)

10000

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 Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

It is a international multicenter registry study conducted at 4 centers (Queen Elizabeth Hospital II, Peking Shougang Hospital, Ulsan Medical Center, and Ulsan University Hospital) expert in patients with de novo coronary lesion who received DCB treatment.

Description

Inclusion Criteria:

- de novo coronary artery disease

Exclusion Criteria:

  • unstable hemodynamics at presentation
  • life expectancy <1 year

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulsan Medical Center
Division of Cardiology, Department of Internal Medicine, Ulsan Medical Center, Ulsan, South Korea
Device: drug-coated balloon
drug-coated balloon
Queen Elizabeth Hospital
Cardiology Department and Clinical Research Center, Queen Elizabeth Hospital II, Kota Kinabalu, Malaysia
Device: drug-coated balloon
drug-coated balloon
Pecking University Shougand Hospital
Department of Cardiology, Peking University Shougang Hospital, Peking, China
Device: drug-coated balloon
drug-coated balloon
Ulsan University Hospital
Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea
Device: drug-coated balloon
drug-coated balloon
Kangwon National University School of Medicine
Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea
Device: drug-coated balloon
drug-coated balloon
Korea University Guro Hospital
Cardiovascular Center, Department of Cardiology, Korea University Guro Hospital, Seoul, South Korea
Device: drug-coated balloon
drug-coated balloon
Korea University Ansan Hospital
Department of Cardiology, Korea University Ansan Hospital, Ansan, South Korea
Device: drug-coated balloon
drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events at 12 months
Time Frame: 12 months

Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding [BARC type 3 to 5]) at 12 months.

  1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
  2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic and clinical outcomes
Time Frame: 12, 24, 36 months

  • MACE at 12, 24, 36 months

    • The single components of the primary endpoint after 12, 24, 36 months. Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding after 12, 24, 36 months.1 (All events will be adjudicated by an independent Critical Events Committee).

      • Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, 36 months.

        • Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation

          • Cost-effectiveness of DCB vs. DES after 12, 24, 36 months.

            • All-cause death ⑥ Stroke (ischemic and hemorrhagic)

              • Angina severity measured with Seattle Angina Questionnaires at 12, 24 months

                • Total procedure time, fluoroscopy time, contrast volume, number of stents used ⑨ DAPT duration ⑩ Periprocedural MI rate ⑪ Sex difference in MACE between DCB vs. DES ⑫ Comparison of MACE between DCB vs. DES in DM patients
12, 24, 36 months

Collaborators and Investigators

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

Sponsor

Ulsan Medical Center

Investigators

  • Principal Investigator: Soo-Jin Kim, IRB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 22, 2011

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • USH-20-004 (Registry Identifier: Ulsan Medical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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