CTRI/2012/01/002393已完成4 期
A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. - Superia Study
Innvolution Med System0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •GENERAL INCLUSION CRITERIA:
- •1.Patient with age > 18 years
- •2.Patient who are suitable for implantation of one or more Superia-Sirolimus Eluting Coronary Stent System in one or more native artery target lesions
- •3. Patient agrees to participate in the study by signing the EC approved informed consent form.
- •4. Patient with indication,lesion length and target lesion vessel diameter according to the Indications and Instructions for Use given with every Superia-Sirolimus Eluting Coronary Stent System.
- •5. The patient who fully agrees and are able to cooperate with registry procedures and required follow up.
- •6. Patient must agree not to participate in any other clinical study for a period of 2 years following the index procedure.
- •ANGIOGRAPHIC INCLUSION CRITERIA:
- •1.Target lesion must be located in native coronary artery with estimated diameter between 2.5 to 3.5 mm by visual estimation
- •2.Treatment of two de novo lesions, each located in a separate native epicardial vessel.
- •3.Target lesion(s) must measures 28 mm by length by visual estimation.
- •4.The target lesion must be a major artery or branch with a visually estimated stenosis of greater than equal to 50% and less than 100% with a timi flow of greater or equal to 1.
- •5. Percutaneous interventions in the target vessel (including side branches) is allowed if done greater than equal to 9 months prior to the index procedure
- •6. Percutaneous interventions in non target vessel (including side branches) is allowed if (a)Successful and uncomplicated (visually estimated diameter stenosis less than 50%, TIMI grade-3 flow, no ECG changes, prolonged chest pain or angiographic complications) bare metal stent, balloon dilatation, cutting balloon atherectomy, thrombectomy, and laser treatment done more than equal to 24 hrs prior to the index procedure (b)Unsuccessful and complicated bare metal stent, balloon dilatation, cutting balloon atherectomy, thrombectomy, and laser treatment done more than equal to 30 days prior to the index procedure.
- •7. CK and CK-MB must be less than 2 times the upper limit of normal at the time of the index procedure.
排除标准
- •GENERAL EXCLUSION CRITERIA:
- •1. Patient with known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB 2 times of upper limit of normal)and CK and CK-MB not have returned to the upper limit of normal at the time of procedure
- •2. Patient currently experiencing clinical symptoms consistent with AMI
- •3. Patient with current unstable angina
- •4. Patient with known left ventricular ejection fraction (LVEF) of less than 30%
- •5. Patient with heart transplant or any other organ transplant or in waiting list of any organ transplant
- •6. Patients with Acute Coronary Syndrome
- •7. Female patients with known pregnancy or who are lactating
- •8. Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- •9. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- •10. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- •11. Current medical condition with a life expectancy of less than 12 months.
- •12. Patients who are receiving immunosuppressive therapy or have known serious immunosuppressive disease (eg HIV) or have severe autoimmune disease that requires chronic immunosuppressive therapy (eg SLE etc).
- •13. Patients who are receiving or plan to receive the chronic anticoagulation therapy(eg heparin or coumadin).
- •14. Subject has received brachytherapy in any epicardial vessel (including side branches).
- •15. The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this Registry once.
- •16. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this registry.
- •17. Patients with saphenous vein grafts of target vessel.
- •18. Drug eluting stent treatment if done within 90 days prior to the index procedure.
- •19. Subject has known renal insufficiency (eg. Serum creatinine level of greater than 2.5 mg/dL or subject is under dialysis).
- •20. Platelet count less than 1,00,000 cells/mm3 or greater than 7,00,000 cells/mm3, WBC of less than 3,000 cells/mm3 .
- •21. Patients requirement to implant DES other than Superia in any of the lesion of Target Vessel.
- •ANGIOGRAPHIC EXCLUSION CRITERIA:
- •1. Patients with target lesions diagnosed angiographically as Chronic Total Occlusions (TIMI flow 0) prior to wire crossing.
- •2. Patient with ostial lesion in main left coronary artery and left main ostial location (RCA- aorto ostial lesion are not excluded).
- •3. Patients with extreme angulation (>=90â?¦) prior to or within the target lesion.
- •4. Patients with heavy calcification of target vessel.
- •5. Patients with re-stenosis of previous intervention.
- •6. Patient with target vessel containing thrombus.
- •7. Patients with extreme peripheral vascular disease (PVD), that precludes safe 7 French sheath insertion.
- •8. Patient with target lesion located within 2 mm of the origin of left anterior descending (LAD) artery and the left circumflex artery (LCX).
- •9. Patient with target lesion
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