Clinical trial NCT02121223: POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: acute ST segment elevated myocardial infarction
primary percutaneous intervention
Stent Incomplete Apposition
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Shanghai East Hospital
name: Ningbo No. 1 Hospital
First posted: 2014-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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:

  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

Primary outcomes:
measure: Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
timeFrame: 7 months after primary PCI
Secondary outcomes:
measure: Final TIMI flow grade 3
timeFrame: Immediately after primary PCI procedure (up to 2 min)
measure: Final TIMI blush Grade 3
timeFrame: Immediately after primary PCI procedure (up to 2 min)
measure: Rate of ST resolution 70% at 30 day
timeFrame: 30 days after primary PCI
measure: Rate of strut coverage in OCT at 7 month
timeFrame: 7 months after primary PCI
measure: MACE at 7 month and 12 month
timeFrame: 7 months and 12 months after primary PCI
measure: TLR ,TLF at 7 month and 12 month
timeFrame: 7 months and 12months after primary PCI
measure: Stent thrombus rate at 30 day,7 month and 12 month
timeFrame: 30 days, 7 months and 12 months after primary PCI
measure: In-stent and in-segment late loss
timeFrame: 7 months after primary PCI
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Jianan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang J, Tian NL, Cui HB, Li CL, Liu XB, Dong L, Sun Y, Chen XM, Chen SL, Xu B, Wang JA. Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography. World J Emerg Med. 2020;11(2):87-92. doi: 10.5847/wjem.j.1920-8642.2020.02.004.