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To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.
This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedures with the use of StarClose® Vascular Closure System in the femoral artery after diagnostic catheterization procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vessel Closure (StarClose™) | Device |
|
Inclusion:
Exclusion:
Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram)
Procedural Exclusion:
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Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedure
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| Name | Affiliation | Role |
|---|---|---|
| William Kussmaul, MD | Drexel University/Hahnemann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States | ||
| Fuqua Heart Center/ Piedmont Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8874942 | Background | Krone RJ, Johnson L, Noto T. Five year trends in cardiac catheterization: a report from the Registry of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Diagn. 1996 Sep;39(1):31-5. doi: 10.1002/ccd.1810390102. | |
| 8644584 | Background | Waksman R, Scott NA, Ghazzal ZM, Mays R, Frerichs FA, Petersen JY, King SB 3rd. Randomized comparison of flexible versus nonflexible femoral sheaths on patient comfort after angioplasty. Am Heart J. 1996 Jun;131(6):1076-8. doi: 10.1016/s0002-8703(96)90079-4. |
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| Atlanta |
| Georgia |
| 30309 |
| United States |
| Heart Care Midwest (OSF/St Francis) | Peoria | Illinois | 61603 | United States |
| The Care Group LLC (St. Vincent's Hospital) | Indianapolis | Indiana | 46260 | United States |
| Bay Regional Medical Center | Bay City | Michigan | 48708 | United States |
| Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Buffalo Heart group | Buffalo | New York | 14203 | United States |
| North Ohio Research LTD Elyria Regional Medical | Elyria | Ohio | 44035 | United States |
| Drexel University College of Medicine Hahnemann | Philadelphia | Pennsylvania | 19102 | United States |
| 7728861 | Background | Bogart DB, Bogart MA, Miller JT, Farrar MW, Barr WK, Montgomery MA. Femoral artery catheterization complications: a study of 503 consecutive patients. Cathet Cardiovasc Diagn. 1995 Jan;34(1):8-13. doi: 10.1002/ccd.1810340304. |
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| Background | Lincoff AM, Tcheng JE, Miller DP, Booth JE, Montague EA, Topol EJ. Marked enhancement of clinical efficacy of platelet GP IIb/IIIa blockade with c7E3Fab (Abciximab) linked to reduction in bleeding complications: Outcome in the EPILOG and EPIC trials. Circulation 94:I-375, 1996. |
| Background | Goods CM, Liu MW, Jain SP, Mathur A, Yadav JS, Al-Shalbi KF, Dean LS, Iyer SS, Parks JM, Roubin GS. Low molecular weight heparin versus standard heparin in participants at high risk for stent thrombosis: Clinical outcomes. Circulation 94:I-684, 1996. |
| Background | Ernst S, Kloss R, Schräder R, Kaltenbach M, Sigwart U, Sanborn TA. Immediate sealing of arterial puncture sites after catheterization and PTCA using a vascular hemostasis device with collagen: an international study. Circulation 84:I-272, 1991. |
| 9258477 | Background | Silber S, Dorr R, Muhling H, Konig U. Sheath pulling immediately after PTCA: comparison of two different deployment techniques for the hemostatic puncture closure device: a prospective, randomized study. Cathet Cardiovasc Diagn. 1997 Aug;41(4):378-83. doi: 10.1002/(sici)1097-0304(199708)41:43.0.co;2-2. |
| 9422835 | Background | Silber S. Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization. Clin Cardiol. 1997 Dec;20(12):981-92. doi: 10.1002/clc.4960201203. |
| 9453535 | Background | Silber S. Hemostasis success rates and local complications with collagen after femoral access for cardiac catheterization: analysis of 6007 published patients. Am Heart J. 1998 Jan;135(1):152-6. doi: 10.1016/s0002-8703(98)70356-4. |
| 12847195 | Background | Hoffer EK, Bloch RD. Percutaneous arterial closure devices. J Vasc Interv Radiol. 2003 Jul;14(7):865-85. doi: 10.1097/01.rvi.0000071086.76348.8e. |
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| 7759724 | Background | Kussmaul WG 3rd, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandza JG Jr. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol. 1995 Jun;25(7):1685-92. doi: 10.1016/0735-1097(95)00101-9. |
| 11249907 | Background | Kapadia SR, Raymond R, Knopf W, Jenkins S, Chapekis A, Ansel G, Rothbaum D, Kussmaul W, Teirstein P, Reisman M, Casale P, Oster L, Simpfendorfer C. The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry. Am J Cardiol. 2001 Mar 15;87(6):789-91, A8. doi: 10.1016/s0002-9149(00)01507-1. |
| 22162141 | Derived | Burke MN, Hermiller J, Jaff MR. StarClose vascular closure system (VCS) is safe and effective in patients who ambulate early following successful femoral artery access closure--results from the RISE clinical trial. Catheter Cardiovasc Interv. 2012 Jul 1;80(1):45-52. doi: 10.1002/ccd.23176. Epub 2011 Dec 8. |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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