POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment

Study Overview
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Brief Summary
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To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .

Official Title
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A Prospective, Multi-center,Randomized Controled Trial of POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary PCI After Thrombus Aspiration and DES Implantation With OCT Assessment

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: post-dilatation with a Quantum Maverick balloon
* Device: manual thrombus aspiration + Promus Element stent implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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 | Device: manual thrombus aspiration + Promus Element stent implant<br>* manual thrombus aspiration followed by Promus Element stent implantation at normal pressure<br>|
| Experimental: Post-dilatation<br>Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation | Device: post-dilatation with a Quantum Maverick balloon<br>* post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.<br>Device: manual thrombus aspiration + Promus Element stent implant<br>* manual thrombus aspiration followed by Promus Element stent implantation at normal pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month |  | 7 months after primary PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final TIMI flow grade 3 |  | Immediately after primary PCI procedure (up to 2 min) | 
| Final TIMI blush Grade 3 |  | Immediately after primary PCI procedure (up to 2 min) | 
| Rate of ST resolution 70% at 30 day |  | 30 days after primary PCI | 
| Rate of strut coverage in OCT at 7 month |  | 7 months after primary PCI | 
| MACE at 7 month and 12 month |  | 7 months and 12 months after primary PCI | 
| TLR ,TLF at 7 month and 12 month |  | 7 months and 12months after primary PCI | 
| Stent thrombus rate at 30 day,7 month and 12 month |  | 30 days, 7 months and 12 months after primary PCI | 
| In-stent and in-segment late loss |  | 7 months after primary PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition