Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2021-12-30

Brief Summary

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This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).

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Detailed Description

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This is a pilot study that aim to enroll 60 subjects with high bleeding risk.

All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor will remain blinded until the final study results are released.

Study Groups

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non-slip element (NSE) predilation

In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment.

Group Type EXPERIMENTAL

NSE balloon

Intervention Type DEVICE

NSE (Goodman®) predilation + DCB (Sequent® Please) treatment

non-compliant (NC) balloon predilation

In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.

Group Type ACTIVE_COMPARATOR

NC balloon

Intervention Type DEVICE

NC balloon predilation + DCB (Sequent® Please) treatment

Interventions

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NSE balloon

NSE (Goodman®) predilation + DCB (Sequent® Please) treatment

Intervention Type DEVICE

NC balloon

NC balloon predilation + DCB (Sequent® Please) treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
* Coronary artery disease (CAD) patients with high risk of bleeding

Exclusion Criteria

* Previous coronary artery bypass graft (CABG) patients
* Stent implantation in the target vessel
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
* Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
* Contraindications to contrast media, antiplatelet therapy, or paclitaxel
* Cardiac shock
* Pregnancy
* Expected life less than 12 months

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No