NL-OMON29854招募中不适用
A safety evaluation of the Genous Bio-engineered R stent in the treatment of patients with ST segment elevation myocardial infarction. - HEALING AMI study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must meet ALL of the following criteria:
- •1. Patient >= 18 and <= 80 years of age.
- •2. ST-segment elevation of >= 1 mm in >= 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of >= 1 mm in >= 2 contiguous anterior leads.
- •3. Treatment of one or two de novo lesions in the same vessel with a total lesion length of <= 30mm. Patients with multi vessel disease not requiring treatment of other lesions within 30 days following treatment of the infarct lesions may be included.
- •4. Target lesion is located in a native coronary artery.
- •5. Reference vessel diameter >= 2.5 and <= 3.75 mm by visual estimate.
- •6. Total lesion length <= 30mm by visual estimate.
- •7. Acceptable candidate for coronary artery bypass surgery (CABG).
- •8. The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee.
- •9. Must have clinical symptoms consistent with AMI (e.g., angina or anginal equivalent) lasting <= 30 minutes but < 12 hours in duration. If the symptom duration at the time of evaluation is <1 hour, to rule out unstable angina, the symptoms must be unresponsive to nitroglycerin (i.e. ongoing) prior to signing the informed consent. Patients with symptom onset within 12 hours, in whom the symptoms lasted > 1 hour but subsequently resolved, may still be enrolled if the ECG, at the time of the evaluation, shows definitive ongoing ST segment elevation.
排除标准
- •1. Woman who are preganant or woman of childbearing potential who do not use adequate contraception.
- •2. Recipient of heart transplant.
- •3. Any patient who previously received murine therapeutic antibodies and is know to have exhibited sensitization through the production of Human Anti-mouse Antibodies (HAMA).
- •4. Patient with life expectancy less than the follow-up period (12 months).
- •5. Know allergies to aspirin, clopidogrel bisulphate an ticlopidin, heparin or stainless steel.
- •6. Patients pesenting with cardiogenic shock.
- •7. Received thrombolytic therapy for the current STEMI.
- •8. Lesion is not suitable for stenting.
- •9. Any significant medical condition which in the investigator's opinion may interfere with the patient's optinonal participation in the study.
- •10. Currently participatinf in an investigational drug or antother device study or subject to inclusion in another investigational srug or other another device study during follow-up.
- •11. Unprotected left main coronary disease with >50% stenosis.
- •12. Ostial target lesions.
- •13. Calcified lesions which cannot be successfully predilated.
- •14. Targer lesion has excessive tortuosity unsuitable for stent delivery and deplyment.
- •15. Target lesion involves bifurcation including a side brach >2.5 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require stenting of diseased side branch).
- •16. A significant (>50%) stenosis proximal or distal to the target lesion or in another vessel that is not the infarct lesion and requires treatmetn during the acute procedure or within 30 days of enrollment.
- •17. Documented ejection fraction <25% within 6 weeks of patient enrollmetn on th estudy.
- •18. pre-treatment with devices other than balloon angioplasty.
- •19. Prior stent within 10mm target lesion.
- •20. Patient presenting with possible/probable stent thrombosis.
- •21 Any patient in whom angiography demonstrates the infarct lesion to be at the site if a previously implanted stent (bare metal or drug-eluting)
- •22 Patients who underwent coronary stent implamentation within the past 30 days.
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