ThromboAblation in Acute Myocardial Infarction (TAAMI)

University of Glasgow

Status and phase: Terminated; Phase 3; Phase 2

Conditions: ST Elevation Acute Myocardial Infarction

Treatments: Device: PTCA (Direct Stenting); Device: Laser Thromboablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00650975

D001747-01

Details and patient eligibility

About

1. 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.
2. Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

ELCA

Active Comparator group

Description:

Laser Thromboablation

Treatment:

Device: Laser Thromboablation

PTCA

Active Comparator group

Description:

PTCA (Direct Stenting)

Treatment:

Device: PTCA (Direct Stenting)