Acute Myocardial Infarction
Conditions
Keywords
acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition
Brief summary
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 .
Interventions
DEVICEpost-dilatation with a Quantum Maverick balloon
post-dilatation with a Quantum Maverick balloon at high pressure (\>=16atm) for at least 15 seconds.
DEVICEmanual thrombus aspiration + Promus Element stent implant
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Shanghai East Hospital
Ningbo No. 1 Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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: 1. ALL significant lesions are eligible for stenting with study stents, and 2. ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm 3. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month | 7 months after primary PCI |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Final TIMI flow grade 3 | Immediately after primary PCI procedure (up to 2 min) |
| 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 |
| MACE at 7 month and 12 month | 7 months and 12 months after primary PCI |
Countries
China
Contacts
Primary ContactJun Jiang, MD
Outcome results
None listed