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

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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: NSE balloon; Device: NC balloon

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: NFH20190104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No