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Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drug-coated balloon
Drug-eluting stent
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent
  2. Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%.

Exclusion Criteria:

1.Clinical criteria

  1. LVEF<30%
  2. Killip grading is greater than 3
  3. Significant abnormalities in hemorrhagic quality or known coagulation function
  4. History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets < 100,000/mm3 or hemoglobin < 10 g/dL.
  5. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists
  6. The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria

1)Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Drug-coated ballon

    Drug-eluting stent

    Arm Description

    Treatment of in suit coronary lesions with drug-coated balloon

    Treatment of in suit coronary lesions with drug-eluting stent

    Outcomes

    Primary Outcome Measures

    Late luminal loss (LLL)
    LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography

    Secondary Outcome Measures

    Restenosis rate (RR)
    in-stent restenosis
    Target lesion failure (TLF)
    The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
    Target lesion thrombosis
    Thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year)
    MACE
    Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death

    Full Information

    First Posted
    August 20, 2019
    Last Updated
    August 26, 2019
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04072081
    Brief Title
    Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
    Official Title
    Multicenter, Randomized, Open and Controlled Study of Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 30, 2019 (Anticipated)
    Primary Completion Date
    September 30, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang 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
    The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.
    Detailed Description
    The main objective of this study is to compare a Drug-coated Ballon with Drug-eluting stent in the treatment of coronary arty lesions in STEMI patients in de novo coronary lesions.The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug-coated ballon
    Arm Type
    Experimental
    Arm Description
    Treatment of in suit coronary lesions with drug-coated balloon
    Arm Title
    Drug-eluting stent
    Arm Type
    Active Comparator
    Arm Description
    Treatment of in suit coronary lesions with drug-eluting stent
    Intervention Type
    Device
    Intervention Name(s)
    Drug-coated balloon
    Intervention Description
    Treatment of in suit coronary lesions with drug-coated balloon
    Intervention Type
    Device
    Intervention Name(s)
    Drug-eluting stent
    Intervention Description
    Treatment of in suit coronary lesions with drug-eluting balloon
    Primary Outcome Measure Information:
    Title
    Late luminal loss (LLL)
    Description
    LLL was the difference between the in-segment minimal lumen diameter after the procedure and at angiographic follow-up, as evaluated by quantitative coronary angiography
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Restenosis rate (RR)
    Description
    in-stent restenosis
    Time Frame
    12-24 months
    Title
    Target lesion failure (TLF)
    Description
    The occurrence of cardiac death, target vessel myocardial infraction and target vessel revascularization
    Time Frame
    12-24 months
    Title
    Target lesion thrombosis
    Description
    Thrombus was classified as definite, probable, or possible, according to the definitions provided by the Academic Research Consortium (ARC). Regarding timing, ST was defined as early (<30 days), late (30 days to 1 year), or too late (>1 year)
    Time Frame
    12-24 months
    Title
    MACE
    Description
    Non-fatal acute myocardial infarction, severe arrhythmia, heart failure, cardiovascular death
    Time Frame
    12-24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical criteria 1)over 18 years old 2)Angiographic confirmation of acute myocardial infarction 3)EKG prompts STEM basis 4)Sign informed consent Angiographic criteria 1)In situ coronary artery disease 2)The reference diameter of the target vessel was 2.5-3.5 mm and the length was less than 28 mm 3)Visual examination showed that the diameter of lesions in criminals was narrower than or equal to 80%. Exclusion Criteria: 1.Clinical criteria LVEF<30% Killip grading is greater than 3 Significant abnormalities in hemorrhagic quality or known coagulation function History of intracranial tumors, aneurysms, arteriovenous malformations or cerebral hemorrhage;There was a history of stroke or TIA in 6 months and gastrointestinal bleeding in 2 months.Major operations were performed within 6 weeks.Recent or known platelets < 100,000/mm3 or hemoglobin < 10 g/dL. Planned elective surgery may lead to early discontinuation of ADP receptor antagonists The expected survival time of patients with other systemic diseases, such as malignant tumors is less than 1 year 2.Angiographic criteria 1)Left main lesion 2)The grade of dissection is greater than or equal to grade C lesions. 3)Coronary artery bridge lesions 4)In-stent restenosis 5)Severe stenosis of non-criminal lesions requiring selective treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiang Jun, PhD
    Phone
    13588706891
    Email
    hu888po@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiang Jun, PhD
    Organizational Affiliation
    Second Affiliated Hospital Zhejiang University School of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

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