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
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
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
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
NCT ID
NCT04072081
First Posted
August 20, 2019
Last Updated
August 26, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Learn more about this trial
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
We'll reach out to this number within 24 hrs