POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment (POST-STEMI)
Acute Myocardial Infarction
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition
Eligibility Criteria
Clinical Inclusion Criteria:
- Age ≥18 years
- STEMI >20 mins and <12 hours in duration
- ST-segment elevation of ≥1 mm in ≥2 contiguous leads; or Presumably new left bundle branch block; or True posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads
- Written, informed consent
Angiographic Inclusion Criteria
The presence of least 1 acute infarct artery target vessel* in which:
- ALL significant lesions are eligible for stenting with study stents, and
- ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
- All culprit lesion TIMI Flow ≤ 0 or 1 Grade prior to guide wire crossing
- Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification)
- Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)
Clinical Exclusion Criteria:
- Contraindication to any of the study medications
- Patients with cardiogenic shock
- History of bleeding diathesis or known coagulopathy , or will refuse blood transfusions
- History of intracerebral mass, aneurysm, AVM, or hemorrhagic stroke; stroke or TIA within 6 months or any permanent neurologic deficit; GI or GU bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count <100,000 cells/mm3 or hgb <10 g/dL
- Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post enrollment
Angiographic Exclusion Criteria
- Bifurcation lesion definitely requiring implantation of stents in both the main vessel + side branch
- Infarct related artery is an unprotected left main
- >38 mm of study stent length anticipated
- Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent
- High likelihood of CABG within 30 days anticipated
- The culprit lesion will be judged unsuitable for OCT procedure, because of conditions such as left main trunk disease or shock vital
Sites / Locations
- Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
Post-dilatation
Patients in control group will receive current standard therapy for STEMI: manual thrombus aspiration + Promus Element stent implantation ( with a pressure less than 12 atm), but not post-dilatation
Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation