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

Not Applicable

• Conditions: Acute Myocardial Infarction
• Interventions: Device: post-dilatation with a Quantum Maverick balloon; Device: manual thrombus aspiration + Promus Element stent implant

• Registration Number: NCT02121223
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-22
• Last Update Submitted: 2014-04-22
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23
• Primary Completion: 2015-05
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month	7 months after primary PCI

Secondary Outcome Measures

Name	Time	Method
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)
Final TIMI blush Grade 3	Immediately after primary PCI procedure (up to 2 min)
In-stent and in-segment late loss	7 months after primary PCI
Stent thrombus rate at 30 day,7 month and 12 month	30 days, 7 months and 12 months after primary PCI
Rate of ST resolution 70% at 30 day	30 days after primary PCI
TLR ,TLF at 7 month and 12 month	7 months and 12months after primary PCI
MACE at 7 month and 12 month	7 months and 12 months after primary PCI

Trial Locations

Locations (1)

Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China