Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-31 @ 2:32 AM
Study NCT ID:
NCT05680051
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DCB Under the Guidance of OCT in STEMI
Sponsor:
Henan Institute of Cardiovascular Epidemiology
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: