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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03817801
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Study Start: 2019-07-30
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-24
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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