Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT01271361
Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years of age.
* Patients with a ST-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 angiographical visible stenosis (\>30%) or TIMI≤ II in de-novo, native, previously unstented vessel.
* The single vessel coronary artery disease.
* Signed Informed Consent.
* The patient understands and accepts clinical follow-up and OFDI controls.
* Patients residence is in the area covered by hospital. Angiographic
* Vessel size should match available Nobori stent sizes (\<4.0 mm, and \>2.0 mm by visual assessment).
Additional Inclusion criteria (applicable only for France)
* Patients residence is in the area covered by hospital.
* Patient is affiliated to social security or equivalent system.
Exclusion Criteria:
* Pregnancy and women of child bearing potential (less than 50 years of age).
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast material.
* Diameter Stenosis \<30% in the target lesion.
* The multi-vessel coronary artery disease (DS\>50%).
* Unprotected left main disease with a diameter stenosis of \>30% by visual assessment.
* Distal vessel occlusion.
* 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.
* Fibrinolysis prior to PCI.
* Known thrombocytopaenia (PLT\< 100,000/mm3).
* Contraindication to PCI, stenting, ASA, clopidogrel.
* Active bleeding or coagulopathy or patients at chronic anticoagulation therapy.
* Cardiogenic Shock.
* Significant comorbidities precluding clinical follow-up (as judged by investigators).
* Major planned surgery that requires discontinuation of dual antiplatelet therapy.
* Proximal RCA stenosis (\>30%) if the infarct-related artery is mid-RCA or distal-RCA.
* People under judicial protection.
* A patient who has congenital heart disease, severe cardiac valve disorder and/or myocardial disease (excluding status post MI).
* Patient participating in other clinical research study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01271361
Study Brief:
Protocol Section:
NCT01271361