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

Coronary Artery Disease Clinical Trial

— PREPARE-NSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817801
• Other study ID #: NFH20190104
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• NSE balloon
NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
• NC balloon
NC balloon predilation + DCB (Sequent® Please) treatment

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bailout drug-eluting stents (DES) implantation rate	Bailout DES implantation rate during procedure by angiographic criteria	During procedure
Secondary	Fractional Flow Reserve (FFR) value	FFR value after balloon predilation measured by FFR	immediately after balloon predilation
Secondary	Minimum lumen area (MLA)	MLA after procedure by IVUS	immediately after procedure
Secondary	Minimum lumen diameter (MLD)	MLD after procedure by IVUS	immediately after procedure
Secondary	Plaque burden	Plaque burden after procedure by IVUS	immediately after procedure
Secondary	Dissection	Dissection after procedure by IVUS	immediately after procedure
Secondary	Atheroma volume	Atheroma volume after procedure by IVUS	immediately after procedure
Secondary	The diameter stenosis of target lesion	The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography	6 months
Secondary	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
Secondary	The binary restenosis of target lesion	The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography	6 months
Secondary	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