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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NSE balloon
NC balloon
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

non-slip element (NSE) predilation

non-compliant (NC) balloon predilation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Bailout drug-eluting stents (DES) implantation rate
Bailout DES implantation rate during procedure by angiographic criteria
Fractional Flow Reserve (FFR) value
FFR value after balloon predilation measured by FFR
Minimum lumen area (MLA)
MLA after procedure by IVUS
Minimum lumen diameter (MLD)
MLD after procedure by IVUS
Plaque burden
Plaque burden after procedure by IVUS
Dissection
Dissection after procedure by IVUS
Atheroma volume
Atheroma volume after procedure by IVUS
The diameter stenosis of target lesion
The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography
The late lumen loss of target lesion
The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography
The binary restenosis of target lesion
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
The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.

Full Information

First Posted
January 21, 2019
Last Updated
April 24, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03817801
Brief Title
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will remain blinded until the final study results are released.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
non-slip element (NSE) predilation
Arm Type
Experimental
Arm Description
In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment.
Arm Title
non-compliant (NC) balloon predilation
Arm Type
Active Comparator
Arm Description
In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.
Intervention Type
Device
Intervention Name(s)
NSE balloon
Intervention Description
NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
Intervention Type
Device
Intervention Name(s)
NC balloon
Intervention Description
NC balloon predilation + DCB (Sequent® Please) treatment
Primary Outcome Measure Information:
Title
The absolute change in minimal lumen area (MLA)
Description
The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bailout drug-eluting stents (DES) implantation rate
Description
Bailout DES implantation rate during procedure by angiographic criteria
Time Frame
During procedure
Title
Fractional Flow Reserve (FFR) value
Description
FFR value after balloon predilation measured by FFR
Time Frame
immediately after balloon predilation
Title
Minimum lumen area (MLA)
Description
MLA after procedure by IVUS
Time Frame
immediately after procedure
Title
Minimum lumen diameter (MLD)
Description
MLD after procedure by IVUS
Time Frame
immediately after procedure
Title
Plaque burden
Description
Plaque burden after procedure by IVUS
Time Frame
immediately after procedure
Title
Dissection
Description
Dissection after procedure by IVUS
Time Frame
immediately after procedure
Title
Atheroma volume
Description
Atheroma volume after procedure by IVUS
Time Frame
immediately after procedure
Title
The diameter stenosis of target lesion
Description
The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography
Time Frame
6 months
Title
The late lumen loss of target lesion
Description
The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography
Time Frame
6 months
Title
The binary restenosis of target lesion
Description
The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography
Time Frame
6 months
Title
The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis
Description
The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD, PhD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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