ThromboAblation in Acute Myocardial Infarction

ST Elevation Acute Myocardial Infarction Clinical Trial

— TAAMI  

Official title:

ThromboAblation in Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00650975
• Other study ID #: D001747-01
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 26, 2008
• Last updated: January 19, 2011
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: KCRI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Acute Myocardial Infarction

Intervention

Device:
• Laser Thromboablation
Laser Thromboablation using the Spectranetics CVX-300® excimer laser system
• PTCA (Direct Stenting)
Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use

Locations

Country	Name	City	State
Poland	Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology	Katowice
Poland	Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow	Krakow
Poland	Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital	Krakow
Poland	University Hospital No. 1 1st Dept. of Cardiology	Poznan
Poland	Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
KCRI	Spectranetics Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE		60 minutes - 30 days	Yes