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

Study Overview
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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).

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.

Official Title
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Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: NSE balloon
* Device: NC balloon


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-slip element (NSE) predilation<br>In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment. | Device: NSE balloon<br>* NSE (Goodman®) predilation + DCB (Sequent® Please) treatment<br>|
| Active Comparator: non-compliant (NC) balloon predilation<br>In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment. | Device: NC balloon<br>* NC balloon predilation + DCB (Sequent® Please) treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute change in minimal lumen area (MLA) | The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bailout drug-eluting stents (DES) implantation rate | Bailout DES implantation rate during procedure by angiographic criteria | During procedure | 
| Fractional Flow Reserve (FFR) value | FFR value after balloon predilation measured by FFR | immediately after balloon predilation | 
| Minimum lumen area (MLA) | MLA after procedure by IVUS | immediately after procedure | 
| Minimum lumen diameter (MLD) | MLD after procedure by IVUS | immediately after procedure | 
| Plaque burden | Plaque burden after procedure by IVUS | immediately after procedure | 
| Dissection | Dissection after procedure by IVUS | immediately after procedure | 
| Atheroma volume | Atheroma volume after procedure by IVUS | immediately after procedure | 
| The diameter stenosis of target lesion | The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography | 6 months | 
| The late lumen loss of target lesion | The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography | 6 months | 
| The binary restenosis of target lesion | The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography | 6 months | 
| The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis | The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months. | 6 months |