Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions (DCB-denovo)

March 21, 2022 updated by: Xue Yu, Beijing Hospital

Long Term Clinical Outcomes of Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions: a Single Center Registry Study

Drug-coating balloon (DCB) is a new interventional device for treatment of obstructive coronary artery disease (CAD). There is limited data on the long term efficacy and safety of DCB-only strategy for coronary de novo lesions in Asian patients. We therefore carry out this registry study to evaluated the clinical outcomes of paclitaxel DCB in Chinese patients in a real world medical practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

DCB has emerged as a new interventional option to treat obstructive CAD. Characterized by non-stent-based local drug delivery system, DCB has several advantages over drug-eluting stent(DES).Paclitaxel DCB inhibits excessive neointimal hyperplasia of a diseased lesions without leaving a permanent metallic frame, therefore reducing the risk of coronary thrombosis and eliminating adverse events associated with stent fracture, allergic reactions to metal struts or polymer. Since only 1 to 3 months duration of dual anti-platelet therapy(DAPT) is required after DCB intervention, the bleeding risk associated with prolonged DAPT is reduced. DCB angioplasty was proved safe in an all-comers, prospective, multicenter registry and confirmed not inferior to DES when treating small coronary lesions in a randomized clinical trial(BASKET SMALL-2). DCB has been used in"off-label"indications in the"real world" for de novo lesions, especially in vessels with diameter more than 2.75mm, and there is limited data on its long term clinical efficacy and safety in Asian patients in contemporary clinical registries. We therefore sought to evaluate the long term clinical outcome of DCB in treatment of coronary de novo lesions in Chinese patients.

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing 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

Patients with stable angina, unstable angina, myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy. They will receive clinical follow up at 30 days, 3, 6, 12 and 24 months after procedure and one angiographic follow up at 24 months after procedure.

Description

Inclusion Criteria:

  1. Patient-related criteria：

    • Patients with stable angina, unstable angina, myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;
    • Consent to receive clinical follow up at 30 days, 3, 6, 12 and 24 months.
    • Consent to receive one angiographic follow up at 24 months after procedure.

  2. Lesion-related criteria：

    • Target coronary lesions without previous intervention therapy;
    • The lesions was intervened only with DCB;
    • The distance between other lesions requiring intervention therapy and the target lesion must >10mm.

Exclusion Criteria:

  1. Patient-related criteria：

    • Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)]
    • Severe valvular heart disease;
    • Pregnant or breastfeeding women;
    • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;
    • Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;
    • Intorerance to aspirin and/or clopidogrel or other anti platelet drugs;
    • Leukopenia or thrombopenia;
    • Stroke within 6 months prior to the operation;
    • A history of severe hepatic or renal failure.

  2. Lesion-related criteria ：

    • Ostia lesions of left main or right coronary artery;
    • Percutaneous coronary intervention of the graft vessel;
    • Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

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
Paclitaxel DCB for De Novo Coronary Lesions
we define de novo coronary artery lesions as the lesions never been treated with any interventional device, such as POBA, stent, rota ablation, laser etc.
Device: Paclitaxel DCB
The length of the DCB catheter should be chosen to exceed the target lesion for at least 2mm (at both proximal and distalends). The catheter(s) will be inflated for 30 to 60s with a minimum of 7 atm. Predilation of the diseased coronary segment with a uncoated balloon/scoring balloon/cutting balloon before the use of DCB will be encouraged. DES should be implanted if the angiographic result after DCB alone therapy is not satisfactory due to significant recoil/residual stenosis or dissection (Type C-F).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of net adverse cardiac events (NACEs) at 24 months after DCB treatment.
Time Frame: Clinical follow-up at 24 months after the procedure.
A composite endpoint of NACEs, including cardiovascular death, myocardial infarction, target lesion revascularization, target vessel revascularization, stroke, all cause bleeding.
Clinical follow-up at 24 months after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late lumen loss(LLL) at 24 months follow-up
Time Frame: Coronary angiography follow-up at 24 months after the procedure.
LLL is defined as minimal lumen diameter(MLD) at follow-up minus MLD immediately post the procedure according to QCA.
Coronary angiography follow-up at 24 months after the procedure.

Collaborators and Investigators

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

Sponsor

Beijing Hospital

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)

August 1, 2019

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

July 14, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJH DCB for de novo

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.

Clinical Trials on Coronary Disease

Clinical Trials on Paclitaxel DCB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe