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ANGIO-Seal or manual Compression After Coronary intervention Evaluation.


- candidate number1935
- NTR NumberNTR569
- ISRCTNISRCTN22655249
- Date ISRCTN created14-feb-2006
- date ISRCTN requested3-feb-2006
- Date Registered NTR19-jan-2006
- Secondary IDs9051 
- Public TitleANGIO-Seal or manual Compression After Coronary intervention Evaluation.
- Scientific TitleANGIO-Seal or manual Compression After Coronary intervention Evaluation.
- ACRONYMAngiocare
- hypothesisIt is assumed that the incidence of the primary endpoint after manual compression will be 7% and after the Angio-Seal 2%.
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI)
- Inclusion criteriaA. 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.
- Exclusion criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 19-jan-2006
- planned closingdate1-feb-2009
- Target number of participants614
- InterventionsManual compression or Angio-Seal closure device of arteria femoralis after PCI.
- Primary outcomeIncidence of: 1. Severe hematoma at the puncture site or groin bleeding resulting in prolonged hospital stay or transfusion; 2. Arteriovenous fistula formation at the puncture site and/or surgical intervention at the puncture site.
- Secondary outcomeThe decrease of hemoglobin, 1 day after inclusion.
- Timepoints
- Trial web sitehttp://www.diagram-zwolle.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIESDr. J.P. Ottervanger
- Sponsor/Initiator Diagram B.V.
- Funding
(Source(s) of Monetary or Material Support)
St. Jude Medical
- Publications1. 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.
- Brief summaryIt concerns a single center prospective randomized study to compare the Angio-Seal closure device with manual compression in a high-risk patient population. The randomization is 1:1 to receive or not to receive an Angio-Seal. All patients will be treated with aspirin, clopidogrel (with high loading dose ), a glycoprotein 2B/3A inhibitor and unfractioned heparin during the PCI. In addition, a non-randomized group consisting of patients with standard clopidogrel dosing will all be closed with Angio-Seal , and their data included in the analysis as an additional control group.
- Main changes (audit trail)
- RECORD19-jan-2006 - 6-mrt-2006


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