No registrations found.
ID
Source
Brief title
Health condition
Patients undergoing PCI, who have a high risk of bleeding
Sponsors and support
van Nahuysplein 6
8011 NB Zwolle
Intervention
Outcome measures
Primary outcome
Incidence 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 outcome
The decrease of hemoglobin, 1 day after inclusion.
Background summary
It 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.
Study objective
It is assumed that the incidence of the primary endpoint after manual compression will be 7% and after the Angio-Seal 2%.
Intervention
Manual compression or Angio-Seal closure device of arteria femoralis after PCI.
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Inclusion criteria
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.
Exclusion criteria
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL525 |
| NTR-old | NTR569 |
| Other | : 9051 |
| ISRCTN | ISRCTN22655249 |
Summary results
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.