Last updated: January 21, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Planned
Phase
N/A
Condition
Heart Defect
Coronary Artery Disease
Congestive Heart Failure
Treatment
Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Clinical Study ID
NCT04929158
clinical 2020-401
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
-Clinical Inclusion (CI) Criteria: CI. Age > 18 years C2. Onset of STEMI > 30 minutes, but < 12 hours C3. ST segment elevation in at least 2 contiguous leads of≥ 1mm or newlydeveloped LBBB on ECG C4. Willing and able to provide informed consent
- Angiographic Inclusion (AI) Criteria (visual estimate) AI1. Having at least oneinfarct-related coronary artery of which
- the Culprit lesion is suitable for stenting
- the reference diameter of culprit vessel is ≥ 2.5 mm but ≤ 4 mm
- the TIMI flow is ≤ 1 in culprit lesion segment prior to guide wire crossing AI2. Noexcessive tortuosity and calcification in the culprit lesion segment that allowingstent implantation
Exclusion
Exclusion Criteria:
- Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant studymedications CE2. Having cardiogenic shock with hemodynamic instability CE3. A historyof bleeding diathesis or known coagulopathy CE4. A history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months; or a history ofintracranial tumor, aneurysm or arteriovenous malformations; or a history of activepeptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; orplanned major procedure within 6 weeks; or known platelet count < 100,000 /mm3 or Hb < 10 g/dL CE5. Planned surgery which may cause discontinuation of ADP-receptorantagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancyto less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI
- Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unableto identify the culprit lesion AE2. The culprit lesion is located in the left mainartery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previousstent implantation in the culprit lesion segment or STEMI caused by stent thrombosisAE5. Likely CABG procedure within 30 days
Study Design
Treatment Group(s): 1
Primary Treatment: Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)
Phase:
Study Start date:
Estimated Completion Date:
Study Description
Connect with a study center
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang 310009
ChinaPlanned

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