NL-OMON34145
Completed
Not Applicable
Randomized study to assess the effect of thrombus aspiration on flow area in STEMI patients: an Optical Frequency Domain Imaging (OFDI) study - TROFI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myoccardial infarction
- Sponsor
- Terumo
- Enrollment
- 70
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Evaluation of acute thrombus regression effect of anticoagulant for deep vein thrombosis in cancer patientsDeep vein thrombosisJPRN-UMIN000036958Toho University50
Completed
Not Applicable
An observational study for thrombus regression by anti-coagulation therapy in venous thromboembolismVenous thromboembolismJPRN-UMIN000019910Gunma University90
Completed
Not Applicable
An observational study to determine thromboembolism prophylaxis in cancer patientsCTRI/2013/05/003617SanofiSynthelabo India Limited295
Recruiting
Not Applicable
Interventional study on the reduction of thrombus using rivaroxaban for deep vein thrombosis and pulmonary thromboembolismvenous thromboembolismJPRN-UMIN000032996Toho University40
Completed
Not Applicable
An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolismon-small cell lung cancer, small cell lung cancerJPRN-UMIN000020194Shimane University Faculty of Medicine1,025