Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention
Condition: Acute ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with
      ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration
      catheter in 40 patients during primary PCI.
    

Detailed description: 
      Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction.
      The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may
      improve clinical outcomes for patients undergoing primary PCI.

      Little data exists on the degree to which thrombus is removed during thrombectomy and how
      much thrombus remains with the potential for distal embolisation during stent deployment. The
      mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography
      only provides an outline image of the vascular lumen, such questions cannot be adequately
      addressed by this modality alone.

      The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus
      burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus
      removal with an aspiration catheter during primary PCI.

      Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed
      according to our hospital standard working protocol with thrombus aspiration and balloon
      dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be
      undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial
      and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after
      stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen
      enlargement and volume of residual thrombus at each stage. All studies will be undertaken
      with the approval of the local Clinical Research Ethics.

      Aspirated material will be collected and analyzed. Clinical markers such as Troponin release
      and left ventricular function will be assessed.
    

Intervention name(s): Thrombus aspiration (Intravascular Ultrasound catheter (Boston))
Intervention type(s): Device
Intervention description(s): There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction.
All patients will have an Intravascular Ultrasound three times:
At baseline
After thrombus aspiration with a thrombus extraction catheter
After stent deployment
We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such.
Other intervention name(s): Export thrombus aspiration cathether; Intravascular Ultrasound catheter (Boston)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute MI; Primary percutaneous coronary intervention; thrombus aspiration, IVUS