Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention

NCT01878487 | Completed

• 1 other identifier: 09/H0906/85
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute ST Elevation Myocardial Infarction

Keywords

Acute MI; Primary percutaneous coronary intervention; thrombus aspiration, IVUS

Outcome Measures

Primary Outcomes (1)

• Coronary artery lumen expansion after thrombus aspiration in primary percutaneous intervention.

  Degree of thrombus extraction can be visualised immediately by intravascular ultrasound (IVUS) but detailed analysis will be carried out off-line and by histopathology of aspirated material within 4 months.

  Day 1

Study Arms (1)

Only one arm

OTHER

All patients will receive the same treatment, i.e. there is no randomization. There is therefore only one arm, all patients will by treated as per standard practice with thrombus aspiration and stenting as required, the lumen size of the vessel will be assessed with intravascular ultrasound at baseline, after thrombus aspiration and after stenting.

Device: Thrombus aspiration (Intravascular Ultrasound catheter (Boston))

Interventions

Thrombus aspiration (Intravascular Ultrasound catheter (Boston)) DEVICE

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: 1. At baseline 2. After thrombus aspiration with a thrombus extraction catheter 3. 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.

Also known as: Export thrombus aspiration cathether, Intravascular Ultrasound catheter (Boston)

Only one arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 18-75 years old with myocardial infarction with ST-segment elevation
• symptoms of myocardial ischemia lasting more than 30 minutes
• onset of symptoms within 12 hours of hospital presentation
• ST-segment elevation of more than 0.1 mV in two or more leads on the ECG

You may not qualify if:

• inability to obtain informed consent
• use of fibrinolytic drug within 12 hours of presentation
• comorbidity with anticipated life expectancy of \< 6 months
• cardiogenic shock on presentation
• major bleeding diathesis
• history of aspirin and clopidogrel intolerance
• critical left main stem lesions
• severe calcfic disease precluding safe passage of the imaging catheter
• culprit lesion within saphenous vein grafts

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Department of Cardiology, Freeman Hospital

Newcastle, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: June 17, 2013
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

GB (1)