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DCB Under the Guidance of OCT in STEMI

Primary Purpose

Acute ST-segment Elevation Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug-eluting balloon
Drug-eluting stent
Sponsored by
Henan Institute of Cardiovascular Epidemiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST-segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 Definitely diagnosed as acute ST segment elevation myocardial infarction according to diagnostic criteria Time of onset ≤ 12h Voluntary signing of informed consent After pretreatment, the culprit vessel participates in stenosis ≤ 30%, no type C (or OCT shows that the dissection involves the middle membrane, and the angle is ≥ 90 degrees) or above, no hematoma, and no obvious thrombus (TIMI thrombus load rating ≤ 2) Exclusion Criteria: Time of onset>12h Those who are allergic to contrast agents, aspirin tablets and Tigrilol tablets; Active bleeding or recent bleeding history Cardiogenic shock and long-term cardiopulmonary resuscitation; The life span is expected to be less than 12 months Angiography showed left main trunk lesion; Angiography shows patients with in stent restenosis Patients who the investigator thinks may affect the normal progress of the study or cannot cooperate well with the study or may cause obvious risks, such as alcoholics or drug abusers, cancer, serious liver, kidney, lung, endocrine (such as uncontrolled diabetes or thyroid disease), nervous or blood system diseases; Known or suspected pregnancy (baseline ß - hCG pregnancy test must be conducted for women in childbearing period), women in menstrual period. The criminal blood vessel has C-type or above dissection after pretreatment, and there is coronary hematoma. After pretreatment, criminal vessels still have obvious thrombus residues (TIMI thrombus load grade ≥ 3) OCT confirms that the criminal lesion is caused by plaque erosion

Sites / Locations

  • Fuwai Central China Cardiovascular HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Drug-coated Balloon (Lepu Medical Technology (Beijing) Co.,Ltd.)

Drug Eluting Stent(Microport Medical)

Outcomes

Primary Outcome Measures

Late lumen loss rate

Secondary Outcome Measures

Revascularization rate of target lesions
Target vessel revascularization rate
Major Adverse Cardiovascular Events
Cardiovascular death
Recurrent acute myocardial infarction
Time-to-onset for recurrent acute myocardial infarction, as ascertained according to follow-up
Stroke
Time-to-onset for stroke, as ascertained according to follow-up
All cause of death
Unstable angina
Time-to-onset for unstable angina, as ascertained according to follow-up

Full Information

First Posted
December 14, 2022
Last Updated
March 22, 2023
Sponsor
Henan Institute of Cardiovascular Epidemiology
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1. Study Identification

Unique Protocol Identification Number
NCT05680051
Brief Title
DCB Under the Guidance of OCT in STEMI
Official Title
A Prospective, Multi-center, Randomized, Parallel Controlled Clinical Trial of Drug Coated Balloon Under the Guidance of OCT in the Treatment of Acute ST-segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acute ST segment elevation myocardial infarction (STEMI) has a high disability mortality rate, and timely reperfusion treatment can significantly reduce the mortality of patients. Emergency PCI is the preferred strategy for STEMI treatment recommended by domestic and international guidelines. The long-term existence of stents can never completely avoid the formation of thrombosis in the stents and affect the relaxation and contraction of criminal blood vessels. Drug coated balloon provides a new concept and technology of interventional therapy for coronary artery disease in the form of "intervention without implantation". Through balloon dilation of local blood vessels to release anti proliferative drugs to coronary artery wall and inhibit intimal hyperplasia, it can not only treat serious coronary artery disease, improve coronary blood supply and vascular function, but also not leave permanent implants in the blood vessels; The main pathogenesis of STEMI is thrombosis based on the rupture or erosion of coronary atheromatous plaque. In terms of pathophysiological mechanism, drug coated balloons are also suitable for STEMI patients without obvious thrombosis or severe dissection after full pretreatment. The two-dimensional lumen images obtained by traditional coronary angiography can not directly reflect the vessel wall, so we can not evaluate the actual size of the vessel, plaque characteristics and the effect of intervention through coronary angiography; Optical coherence tomography (OCT) uses near-infrared scanning to produce high-resolution tissue microscopic images with a resolution of up to 10 μ m. It can clearly observe the three-layer structure of coronary artery, find abnormal intima structure, and more clearly identify thrombosis, dissection, plaque erosion or collapse in coronary artery, providing more valuable information for optimizing interventional treatment. Therefore, the application of drug coated balloon under the guidance of OCT in STEMI can provide a more accurate and optimized diagnosis and treatment scheme for STEMI patients.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Drug-coated Balloon (Lepu Medical Technology (Beijing) Co.,Ltd.)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Drug Eluting Stent(Microport Medical)
Intervention Type
Device
Intervention Name(s)
Drug-eluting balloon
Intervention Description
Drug eluting balloon was used in the experimental group
Intervention Type
Device
Intervention Name(s)
Drug-eluting stent
Intervention Description
Drug eluting stent was used in the control group
Primary Outcome Measure Information:
Title
Late lumen loss rate
Time Frame
10 months after discharge.
Secondary Outcome Measure Information:
Title
Revascularization rate of target lesions
Time Frame
10 months after discharge.
Title
Target vessel revascularization rate
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
Major Adverse Cardiovascular Events
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
Cardiovascular death
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
Recurrent acute myocardial infarction
Description
Time-to-onset for recurrent acute myocardial infarction, as ascertained according to follow-up
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
Stroke
Description
Time-to-onset for stroke, as ascertained according to follow-up
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
All cause of death
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.
Title
Unstable angina
Description
Time-to-onset for unstable angina, as ascertained according to follow-up
Time Frame
1 month after discharge, 3 months after discharge, 6 months after discharge, 10 months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 Definitely diagnosed as acute ST segment elevation myocardial infarction according to diagnostic criteria Time of onset ≤ 12h Voluntary signing of informed consent After pretreatment, the culprit vessel participates in stenosis ≤ 30%, no type C (or OCT shows that the dissection involves the middle membrane, and the angle is ≥ 90 degrees) or above, no hematoma, and no obvious thrombus (TIMI thrombus load rating ≤ 2) Exclusion Criteria: Time of onset>12h Those who are allergic to contrast agents, aspirin tablets and Tigrilol tablets; Active bleeding or recent bleeding history Cardiogenic shock and long-term cardiopulmonary resuscitation; The life span is expected to be less than 12 months Angiography showed left main trunk lesion; Angiography shows patients with in stent restenosis Patients who the investigator thinks may affect the normal progress of the study or cannot cooperate well with the study or may cause obvious risks, such as alcoholics or drug abusers, cancer, serious liver, kidney, lung, endocrine (such as uncontrolled diabetes or thyroid disease), nervous or blood system diseases; Known or suspected pregnancy (baseline ß - hCG pregnancy test must be conducted for women in childbearing period), women in menstrual period. The criminal blood vessel has C-type or above dissection after pretreatment, and there is coronary hematoma. After pretreatment, criminal vessels still have obvious thrombus residues (TIMI thrombus load grade ≥ 3) OCT confirms that the criminal lesion is caused by plaque erosion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junhui Zhang, Dr
Phone
+86 0371 58681033
Email
09junhuizhang@163.com
Facility Information:
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhui Zhang, Dr
Phone
0371 58681033
Email
09junhuizhang@163.com

12. IPD Sharing Statement

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DCB Under the Guidance of OCT in STEMI

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