POST-dilatation to Improve Outcomes in Acute STEMI Patien... | NCT02121223

Status Module

Name	Class
The First Affiliated Hospital with Nanjing Medical University	OTHER
Shanghai East Hospital	OTHER
Ningbo No. 1 Hospital	OTHER

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	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
Post-dilatation	Experimental	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 Device: manual thrombus aspiration + Promus Element stent implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
post-dilatation with a Quantum Maverick balloon	Device	post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.	Post-dilatation

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

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)

Eligibility Module

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

Name	Role	Phone	Extension	Email
Jun Jiang, MD	Contact	8657187784705		drjayj@hotmail.com

Name	Affiliation	Role
Jianan Wang, MD	Second Affiliated Hospital Zhejiang University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Second Affiliated Hospital Zhejiang University School of Medicine		Hangzhou	Zhejiang	310009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32076473	Derived	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.