Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
- Conditions
- Coronary Artery Disease
- Interventions
- Device: NSE balloonDevice: NC balloon
- Registration Number
- NCT03817801
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
- Coronary artery disease (CAD) patients with high risk of bleeding
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description non-slip element (NSE) predilation NSE balloon In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment. non-compliant (NC) balloon predilation NC balloon In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.
- Primary Outcome Measures
Name Time Method The absolute change in minimal lumen area (MLA) 6 months The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
- Secondary Outcome Measures
Name Time Method Bailout drug-eluting stents (DES) implantation rate During procedure Bailout DES implantation rate during procedure by angiographic criteria
Plaque burden immediately after procedure Plaque burden after procedure by IVUS
Dissection immediately after procedure Dissection after procedure by IVUS
Fractional Flow Reserve (FFR) value immediately after balloon predilation FFR value after balloon predilation measured by FFR
Minimum lumen area (MLA) immediately after procedure MLA after procedure by IVUS
Minimum lumen diameter (MLD) immediately after procedure MLD after procedure by IVUS
The diameter stenosis of target lesion 6 months The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography
The binary restenosis of target lesion 6 months The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography
The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis 6 months The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.
The late lumen loss of target lesion 6 months The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography
Atheroma volume immediately after procedure Atheroma volume after procedure by IVUS
Trial Locations
- Locations (1)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China