Complete Infarct Related Artery Revascularization (CORAMI)

Fundacja Ośrodek Badań Medycznych

Status: Terminated

Conditions: Coronary Artery Disease; Myocardial Infarction

Treatments: Procedure: IRA stenting; Procedure: IRA stenting in culprit lesion only

Study type: Interventional

Funder types: Other

Identifiers

NCT01218815

3.0/2010

Details and patient eligibility

About

CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of STEMI (according to ESC 2007 definition)
• Chest pain onset <12 hours
• signed informed consent
• Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery)
• Target/culprit lesion which requires immediate stenting (>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
• Over 18 years of age
• IRA diameter ≥ 2.5 mm

Exclusion criteria

• Terminal illness with life expectancy less <1 year or active cancer disease - Pregnancy or possibility of pregnancy
• Second critical lesion in IRA >90% or occlusion
• Contraindications to PCI or/and stent implantation
• Contraindications to DES stent implantation
• Lesion diameters unsuitable for intended stent platform
• Active bleeding or coagulopathy
• Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
• Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
• No future patient cooperation expected
• Patient is participating in another clinical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Culprit lesion IRA Revascularization

Experimental group

Description:

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

Treatment:

Procedure: IRA stenting in culprit lesion only

Complete IRA revascularization

Active Comparator group

Description:

Primary PCI of culprit lesion in IRA with DES stent

Treatment:

Procedure: IRA stenting