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

Acute Myocardial Infarction Clinical Trial

— POST-STEMI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02121223
• Other study ID #: SAHZJU CT002
• Status: Not yet recruiting
• Phase: N/A
• First received: April 3, 2014
• Last updated: April 22, 2014
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2014
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jun Jiang, MD
• Phone: 8657187784705
• Email: drjayj[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• post-dilatation with a Quantum Maverick balloon
post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.
• manual thrombus aspiration + Promus Element stent implant
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure

Locations

Country	Name	City	State
China	Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Ningbo No. 1 Hospital, Shanghai East Hospital, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month		7 months after primary PCI	Yes
Secondary	Final TIMI flow grade 3		Immediately after primary PCI procedure (up to 2 min)	Yes
Secondary	Final TIMI blush Grade 3		Immediately after primary PCI procedure (up to 2 min)	Yes
Secondary	Rate of ST resolution 70% at 30 day		30 days after primary PCI	Yes
Secondary	Rate of strut coverage in OCT at 7 month		7 months after primary PCI	Yes
Secondary	MACE at 7 month and 12 month		7 months and 12 months after primary PCI	Yes
Secondary	TLR ,TLF at 7 month and 12 month		7 months and 12months after primary PCI	Yes
Secondary	Stent thrombus rate at 30 day,7 month and 12 month		30 days, 7 months and 12 months after primary PCI	Yes
Secondary	In-stent and in-segment late loss		7 months after primary PCI	No