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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)

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ClinicalTrials.gov Identifier: NCT03817801
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Junjie Zhang, Nanjing First Hospital, Nanjing Medical University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: NSE balloon Device: NC balloon Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will remain blinded until the final study results are released.
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The absolute change in minimal lumen area (MLA) [ Time Frame: 6 months ]
    The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)


Secondary Outcome Measures :
  1. Bailout drug-eluting stents (DES) implantation rate [ Time Frame: During procedure ]
    Bailout DES implantation rate during procedure by angiographic criteria

  2. Fractional Flow Reserve (FFR) value [ Time Frame: immediately after balloon predilation ]
    FFR value after balloon predilation measured by FFR

  3. Minimum lumen area (MLA) [ Time Frame: immediately after procedure ]
    MLA after procedure by IVUS

  4. Minimum lumen diameter (MLD) [ Time Frame: immediately after procedure ]
    MLD after procedure by IVUS

  5. Plaque burden [ Time Frame: immediately after procedure ]
    Plaque burden after procedure by IVUS

  6. Dissection [ Time Frame: immediately after procedure ]
    Dissection after procedure by IVUS

  7. Atheroma volume [ Time Frame: immediately after procedure ]
    Atheroma volume after procedure by IVUS

  8. The diameter stenosis of target lesion [ Time Frame: 6 months ]
    The diameter stenosis of target lesion from post-procedure to 6-month follow-up by angiography

  9. The late lumen loss of target lesion [ Time Frame: 6 months ]
    The late lumen loss of target lesion from post-procedure to 6-month follow-up by angiography

  10. The binary restenosis of target lesion [ Time Frame: 6 months ]
    The binary restenosis of target lesion from post-procedure to 6-month follow-up by angiography

  11. The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis [ Time Frame: 6 months ]
    The composite of cardiac death, myocardial infarction, TLR, and target lesion thrombosis at 6 months.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817801


Contacts
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Contact: Jun-jie Zhang, MD, PhD +86-25-52271350 jameszll@163.com
Contact: Xiao-Fei Gao, MD, PhD +86-25-52271350 gaoxiaofei2014@163.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Principal Investigator: Shaoliang Chen, MD         
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Chair: Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University
More Information
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Responsible Party: Junjie Zhang, Vice Director of Cardiovascular Department, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03817801    
Other Study ID Numbers: NFH20190104
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases