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

NCT ID: NCT02121223

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-07-31

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 .

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

manual thrombus aspiration + Promus Element stent implant

Intervention Type: DEVICE

manual thrombus aspiration followed by Promus Element stent implantation at normal pressure

Post-dilatation

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

Group Type: EXPERIMENTAL

post-dilatation with a Quantum Maverick balloon

Intervention Type: DEVICE

post-dilatation with a Quantum Maverick balloon at high pressure (\>=16atm) for at least 15 seconds.

manual thrombus aspiration + Promus Element stent implant

Intervention Type: DEVICE

manual thrombus aspiration followed by Promus Element stent implantation at normal pressure

Interventions

post-dilatation with a Quantum Maverick balloon

post-dilatation with a Quantum Maverick balloon at high pressure (\>=16atm) for at least 15 seconds.

Intervention Type: DEVICE

manual thrombus aspiration + Promus Element stent implant

manual thrombus aspiration followed by Promus Element stent implantation at normal pressure

Intervention Type: DEVICE

Eligibility Criteria

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

• 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)

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian'an Wang,MD,PhD

Professor, Chief of Heart Center, and President of the Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital Zhejiang University School of Medicine

Locations

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Jun Jiang, MD

Role: CONTACT

drjayj@hotmail.com

8657187784705

Facility Contacts

Jun Jiang, MD

Role: primary

drjayj@hotmail.com

8657187784705

References

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.

Reference Type: DERIVED

PMID: 32076473 (View on PubMed)

Other Identifiers

SAHZJU CT002

Identifier Type: -

Identifier Source: org_study_id