Randomized study to assess the effect of thrombus aspiration on flow area in STEMI patients: an Optical Frequency Domain Imaging (OFDI) study

Completed

• Conditions: Myoccardial infarction; 10011082

• Registration Number: NL-OMON34145
• Lead Sponsor: Terumo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Patient is at least 18 years of age
2. Patients with ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with >=2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting >=20 min and having an angiographically visible stenosis (>30%) or TIMI<= II in de-novo, native, previously unstented vessel
3. The single vessel coronary artery disease
4. Signed Informed Consent
5. The patient understands and accepts clinical follow-up and OFDI controls.
6. Patients residence is in the area covered by hospital
7.Vessel size should match available Nobori stent sizes (<4.0 mm, and >2.0 mm by visual assessment)

Exclusion Criteria

1. Pregnancy
2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast
3. Diameter Stenosis <30% in the target lesion
4. The multi-vessel coronary artery disease (DS>50%)
5. Unprotected left main coronary artery stenosis >30% by visual assessment
6. Distal vessel occlusion
7. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter
8. Fibrinolysis prior to PCI
9. Known thrombocytopaenia (PLT< 100,000/mm3)
10. Contraindications to PCI, stenting, ASA, clopidogrel
11. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
12. Cardiogenic Shock
13. Significant comorbidities precluding clinical FU (as judged by investigators)
14. Major planned surgery that requires discontinuation of dual antiplatelet therapy
15. Proximal RCA stenosis (>30%) if the infarct-related artery is mid or distal-RCA

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Minimal Flow Area post-stenting assessed by OFDI</p><br>