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

NCT02121223 | Unknown DMC

• 1 other identifier: SAHZJU CT002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

acute ST segment elevated myocardial infarction; primary percutaneous intervention; Stent Incomplete Apposition

Outcome Measures

Primary Outcomes (1)

• Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month

  7 months after primary PCI

Secondary Outcomes (8)

• 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)

• Rate of ST resolution 70% at 30 day

  30 days after primary PCI

• Rate of strut coverage in OCT at 7 month

  7 months after primary PCI

• MACE at 7 month and 12 month

  7 months and 12 months after primary PCI

Study Arms (2)

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

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

manual thrombus aspiration + Promus Element stent implant DEVICE

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

Control; Post-dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ALL significant lesions are eligible for stenting with study stents, and
• ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Shanghai East Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• 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.

  PMID: 32076473 DERIVED

Study Officials

• Jianan Wang, MD

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jiang, MD

CONTACT

8657187784705; drjayj@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Heart Center, and President of the Hospital

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 23, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

CN (1)