NCT00650975TerminatedPhase 2
ThromboAblation in Acute Myocardial Infarction
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- KCRI
- Enrollment
- 78
- Locations
- 10
- Primary Endpoint
- Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Study Overview
Brief Summary
- Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
- Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Electrocardiographic inclusion criteria: (baseline 12-lead ECG recorded at 25 mm/second upon arrival at investigational center)
- •STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.
- •Angiographic inclusion criteria after crossing with guidewire:
- •IRA is a native coronary artery; and,
- •Reference vessel diameter 2.5 - 4.0 mm; and,
- •TIMI 0 or 1 flow with any TIMI thrombus grade; or,
- •TIMI 2 or 3 flow with TIMI thrombus grade 3 or greater
Exclusion Criteria
- •Patient unwilling or unable to give informed consent
- •Previous MI in the distribution of the current IRA
- •Previous CABG
- •Contraindications to PCI
- •allergy(s) to intended study medications
- •contraindicated for stent implantation
- •Active bleeding or coagulopathy
- •Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP or vasopressors)
- •Known left ventricular ejection fraction (EF) <30%
- •Fibrinolytic administered before PCI
- •Renal insufficiency (creatinine >2.0mg/dl)
- •Current vitamin K antagonist therapy or known INR >1.5
- •Known thrombocytopenia - platelets <100,000 cell count
- •Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
- •Known history of hemorrhagic stroke (CVA or TIA) <2 years before screening
- •Known or suspected pregnancy
- •Current cancer disease
- •Comorbidity where survival is anticipated to be <1 year.
- •No future patient cooperation expected
- •Patient is participating in another clinical study
- •Patient <18 years of age
Outcomes
Primary Outcomes
Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
Time Frame: 60 minutes - 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (10)
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