Clinical trial NCT00650975: ThromboAblation in Acute Myocardial Infarction
Official title: ThromboAblation in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: ST Elevation Acute Myocardial Infarction
Keywords: STEMI
Laser
Thrombus
Thrombectomy
Lead sponsor: KCRI
Sponsor class: OTHER
Collaborators: name: Spectranetics Corporation
First posted: 2008-04-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE
timeFrame: 60 minutes - 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology
city: Krakow
country: Poland
facility: Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital
city: Krakow
country: Poland
facility: Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
city: Poznan
country: Poland
facility: University Hospital No. 1 1st Dept. of Cardiology
city: Warsaw
country: Poland
facility: Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory
Study officials:
affiliation: Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
name: Dariusz Dudek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: