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

Zhejiang University

Status: Unknown

Conditions: Acute Myocardial Infarction

Treatments: Device: manual thrombus aspiration + Promus Element stent implant; Device: post-dilatation with a Quantum Maverick balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02121223

SAHZJU CT002

Details and patient eligibility

About

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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Device: manual thrombus aspiration + Promus Element stent implant

Post-dilatation

Experimental group

Description:

Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation

Treatment:

Device: post-dilatation with a Quantum Maverick balloon

Device: manual thrombus aspiration + Promus Element stent implant