Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Clinical Efficacy and Safety of Drug-coated Balloon

NCT05133921

Coronary Heart Disease Angioplasty, Balloon

COMPLETED

Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions

NCT04561739

De Novo Stenosis Coronary Artery Disease

ACTIVE_NOT_RECRUITING NA

Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients

NCT05937230

Coronary Heart Disease Angioplasty, Balloon

ACTIVE_NOT_RECRUITING

PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)

NCT03155971

Stable Angina Pectoris Unstable Angina Pectoris

UNKNOWN NA

Drug-coating Balloon Treatment in Coronary Artery Disease

NCT04255563

Coronary Artery Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Paclitaxel DCB

Intervention Type DEVICE

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No