Comparison of Clinical Outcomes of IVUS -Guided and Angiography-guided PCI in Patients With Acute STEMI

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

To compare the long-term clinical outcomes of IVUS-guided vs angiography-guided PCI in patients with acute STEMI

Eligibility criteria

Qualifiers

Angiographic Inclusion (AI) Criteria (visual estimate) AI1. Having at least one infarct-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. No excessive tortuosity and calcification in the culprit lesion segment that allowing stent implantation

Disqualifiers

Clinical Exclusion (CE) Criteria CE1. Contraindicating to any concomitant study medications CE2. Having cardiogenic shock with hemodynamic instability CE3. A history of 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 of intracranial tumor, aneurysm or arteriovenous malformations; or a history of active peptic ulcer or active gastrointestinal (GI) bleeding within the past 2 months; or planned 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-receptor antagonist CE6. Other serious illness (e.g., cancer) that may reduce life expectancy to less than 1 year CE7. Repeated MI within 7 days of hospitalization for acute MI

Angiographic Exclusion (AE) Criteria (visual estimate) AE1. Bifurcated lesion unable to identify the culprit lesion AE2. The culprit lesion is located in the left main artery. AE3. Diffusive lesions without distinguishable culprit lesion AE4. Previous stent implantation in the culprit lesion segment or STEMI caused by stent thrombosis AE5. Likely CABG procedure within 30 days

Trial design

Treatments tested in this trial

  • Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)

Treatment groups

No treatment groups listed

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Zhejiang University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Taizhou First People's Hospital

Collaborator

Changxing People's Hospital

Collaborator