NL-OMON28741招募中不适用
ANGIO-Seal or manual CompressionAfter Coronary intervention Evaluation.
Diagram B.V.van Nahuysplein 68011 NB Zwolle0 个研究点目标入组 614 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 614
研究概览
简要总结
- Resnic F, Blake G, Ohno-Machado L, Selwyn A, Popma J, Rogers C. Vascular closure devices and the risk of vascular complications after percutaneous coronary intervention in patients receiving glycoprotein IIb-IIIa inhibitors. Am J Cardiol. 2001;88:493-496. 2. Omoigui N, Califf R, Pieper K, et al. Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Artherectomy Trial (CAVEAT-I). J Am Coll Cardiol. 1995;26:922-930. 3. Oweida SW, Roubin, GS, Smith RB III, Salam AQA. Postcatheterization vascular complications associated with percutaneous transluminal coronary angioplasty. J Vasc Surg 1990;12:310-5. 4. McCann Rl, Schwartz LB, Pieper KS. Vascular complications of cardiac catheterization. J Vasc Surg 1991;14:375-81. 5. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol 1992;69:63-8. 6. Juergens CP, Leung DY, Crozier JA, et al. Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention. Catheter Cardiovasc Interv 2004;63:166-70. 7. Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial Puncture Closing Devices Compared With Standard Manual Compression After Cardiac Catheterization. JAMA 2004;291:350-7. 8. Vaitkus PT. A meta-analysis of percutaneous vascular closure devices after diagnostic catheterization and percutaneous coronary intervention. J Invasive Cardiol 2004;16:243-6. 9. Kastrati A, Mehilli J, Schuhlen H, et al. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med 2004;350:232-8. 10. Lenderink T, Boersma E, Ruzyllo W, et al. Bleeding events with abciximab in acute coronary syndromes without early revascularization: An analysis of GUSTO IV-ACS. Am Heart J. 2004;147:865-73. 11. Exaire JE, Dauerman HL, Topol EJ, et al. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J 2004;147:31-4. 12. Boccalandro F, Assali A, Fujise K, Smalling RW, Sdringola S. Vascular access site complications with the use of closure devices in patients treated with platelet glycoprotein IIb/IIIa inhibitors during rescue angioplasty. Cather Cardiovasc Interv 2004;63;284-9.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •A. Percutaneous Coronary Intervention via the femoral artery, with either B or C;
- •B. At least the following medication:
- •1. Aspirin
- •2. Unfractionated Heparin
- •3. Clopidogrel 600mg pre-loading dose
- •4. Glycoprotein 2B/3A inhibitor;
- •C. PCI within 4 hours after administration of thrombolysis.
排除标准
- •1. Age < 18 years;
- •2. Serious comorbidity such as cancer;
- •3. Advanced cerebrovascular disease;
- •4. Unwilling or unable to sign the consent form for participation;
- •5. Females of childbearing age not using medically prescribed contraceptives;
- •6. Unsuitable access site (severe PVD, poor location).
研究者
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