Complete Lesion Versus Culprit Lesion Revascularization

NCT01180218 | Unknown

• 1 other identifier: KoreaUGuroH_1
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with multivessel disease undergoing percutaneous coronary intervention (PCI) either in infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical practice.

Conditions

Myocardial Infarction

Keywords

myocardial revascularization; myocardial infarction

Interventions

complete revascularization PROCEDURE

-Complete revascularization : one time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions in patient with ST elevateion myocardial infarction (STEMI) and multivessle disease

Culprit revasularization PROCEDURE

Culprit revascularization : PCI of only the culprit lesion and staged nonculprit PCI at a later date in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age.
• Subject is able to verbally confirm understandings of risks, benefits and treatment of culprit or complete revascularization using everolimus eluting coronary stent (Promus™ Element™ Stent) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject must have significant more than two target lesions and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 48hrs
• Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
• Target lesion(s) must be amenable for percutaneous coronary intervention

You may not qualify if:

• The patient has a known hypersensitivity or contraindication to any of the following medications:
• Heparin Aspirin Both Clopidogrel and Ticlopidine Everolimus Platinum chromium Contrast media
• Patients with documented sensitivity to contrast media which can be effectively pre medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
• Systemic (intravenous) everolimus use within 12 months. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
• History of bleeding diathesis or known coagulopathy (including heparin- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months,induced thrombocytopenia), or will refuse blood transfusions.
• An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
• Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Patients with more than 25 percentage of LVEF or those with cardiogenic shock
• Creatinine level more than 3mg per dL or dependence on dialysis.

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Seung Woon Rha

Seoul, South Korea

Location

Related Publications (2)

• Vlaar PJ, Mahmoud KD, Holmes DR Jr, van Valkenhoef G, Hillege HL, van der Horst IC, Zijlstra F, de Smet BJ. Culprit vessel only versus multivessel and staged percutaneous coronary intervention for multivessel disease in patients presenting with ST-segment elevation myocardial infarction: a pairwise and network meta-analysis. J Am Coll Cardiol. 2011 Aug 9;58(7):692-703. doi: 10.1016/j.jacc.2011.03.046.

  PMID: 21816304 RESULT

• Park S, Rha SW, Choi BG, Cho JH, Park SH, Lee JB, Kim YH, Park SM, Choi JW, Park JY, Shin ES, Lee JB, Suh J, Chae JK, Choi YJ, Jeong MH, Cha KS, Lee SW, Kim U, Kim GC, Choi WG, Cho YH, Cho DK, Ahn J, Suh SY, Choi SY, Byun JK, Cha JA, Hyun SJ, Kim JB, Choi CU, Park CG. Immediate versus staged complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel coronary artery disease: results from a prematurely discontinued randomized multicenter trial. Am Heart J. 2023 May;259:58-67. doi: 10.1016/j.ahj.2023.01.020. Epub 2023 Feb 7.

  PMID: 36754106 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Seung Woon Rha

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 12, 2010
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

KR (1)