A Retrospective Study on the Factors of Drug-coated Balloon Restenosis (RE-DCB)

November 12, 2024 updated by: Henan Institute of Cardiovascular Epidemiology
The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. The study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). It primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(Including OCT, IVUS), hemodynamic parameter，and procedural approaches among patients. Over 5000 patients are expected to be enrolled.

Study Type

Observational

Enrollment (Estimated)

5000

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

  • China
      • Zhengzhou, China, 450003
        • Recruiting
        • Fuwai Central China Cardiovascular 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study targets adults aged 18 and over who have been diagnosed with coronary artery disease featuring native large vessel lesions and are scheduled to undergo paclitaxel drug-coated balloon angioplasty.

Description

Inclusion Criteria:

  • Age:

    18 years and older.

  • Diagnosis:

Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.

  • Treatment Plan:

Scheduled to receive paclitaxel drug-coated balloon angioplasty.

  • Informed Consent:

Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.

  • Physiological Status:

Cardiac function classified as NYHA I-III.

Exclusion Criteria:

  • Allergy History:

Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).

  • Severe Complications:

Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).

  • Other Medical Conditions:

Active bleeding or clotting disorders.

  • Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer).
  • Pregnancy or Nursing: Women who are currently pregnant or breastfeeding.
  • Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study.
  • Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 12 months
cardiovascular adverse events:defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LLL(late lumen loss)
Time Frame: 12 months
Detection by QCA technique by subtracting the minimum lumen diameter at review from the minimum lumen diameter in the immediate postoperative period
12 months

Collaborators and Investigators

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

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

  • Study Chair: muwei li, Ph.D, Fuwai central China cardiovascular hospotial

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)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanICE202403

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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