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

Nanjing Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: NC balloon; Device: NSE balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03817801

NFH20190104

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

non-slip element (NSE) predilation

Experimental group

Description:

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

Treatment:

Device: NSE balloon

non-compliant (NC) balloon predilation

Active Comparator group

Description:

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

Treatment:

Device: NC balloon