CompletedNCT00736086Updated Aug 15, 2008

RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System

An observational study in Peripheral Vascular Disease and Cardiovascular Disease, sponsored by Abbott Medical Devices. Completed at 11 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-08-15.

Sponsored by Abbott Medical Devices · Observational

Study type: Observational
Time perspective: Prospective
Enrollment: 165
Ages: 18 Years to 85 Years
Sex: All

Study summary

To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.

Read the detailed description

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.

Conditions studied

Peripheral Vascular Disease
Cardiovascular Disease

Browse trials for

Keywords

femoral artery
post-percutaneous cardiac catheterization
post-percutaneous peripheral vascular catheterization
post-percutaneous diagnostic catheterization
early ambulation
vascular closure

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 165 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedure

Inclusion criteria

Subject must be 18-85.
Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath.
Subject is an acceptable candidate for emergent vascular surgery.
Subject agrees to follow-up evaluations to assess for complications related to femoral access site.
If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit.
Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site.

Exclusion criteria

Exclusion:

History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count \<100,000 cells/mm3, or baseline INR > 1.7.
Body Mass Index (BMI) ³ 35 kg/m2.
Presence of significant anemia (Hgb \< 10 g/dL, Hct \< 30%).
Advanced Subject refusal of blood transfusions, should transfusion become necessary.
Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements.
Pregnant or lactating female.
Clinically severe peripheral vascular disease in the ipsilateral limb, defined as severe claudication (walking \< 100 feet), weak or absent pulses, or lower extremity vascular graft.
History of ipsilateral femoral arterial puncture within previous three months or history of vascular closure device deployment in ipsilateral femoral artery at any time.
Subject has unilateral or bilateral lower extremity amputation(s).
Subject is unable to routinely walk at least 20 feet without assistance.
Subject has an active systemic or cutaneous infection or inflammation.
Subject has a pre-existing severe non-cardiac systemic disease or illness with a life expectancy of \< 30 days.
Subject has already participated in this Study.
Subject has known allergy to nitinol.

Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram)

Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial closure.*
Puncture distal to the common femoral artery bifurcation or above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery on sheath angiogram or the upper third of the femoral head by plain fluoroscopy.*
The arterial lumen diameter at the arteriotomy site is \< 5mm by visual estimate.*
Angiographic evidence of calcified lesions at the arteriotomy site.*
Difficulty inserting the introducer sheath at the start of the catheterization procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time of the percutaneous procedure.
Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in the vicinity of the puncture site.
Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral artery prior to the 30-day follow-up evaluation.
Subject has intra-procedural bleeding around the access site.
Presence or previous use of an intra-aortic balloon pump through the existing arterial puncture site.

Procedural Exclusion:

Low molecular weight heparin administration within 8 hours of enrollment.
For cases where anticoagulants are used, ACT level > 350 seconds at time of enrollment.
Subject is determined to require treatment that will extend hospitalization (e.g. ---Subject is undergoing CABG surgery or staged PTCA).
Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy at time of enrollment.
Placement of an ipsilateral femoral venous sheath during procedure.
Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery prior to arterial closure.
Placement of introducer sheath \< 5F or > 6F during procedure.

Study design

Time perspective: Prospective
Enrollment: 165 participants (actual)

Groups and cohorts

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.
Device: Vessel Closure (StarClose™)

Interventions

DeviceVessel Closure (StarClose™)

Study locations

11 sites

Scripps Memorial Hospital
La Jolla, California 92037, United States
Fuqua Heart Center/ Piedmont Hospital
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

References and documents

Publications

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. PubMed 8874942 ↗
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. PubMed 8644584 ↗
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. PubMed 7728861 ↗
Christensen B, Lacarella C, Manion R, Bruhn-Ding B, Meyer S, Wilson R. Sandbags do not prevent complications after catheterization. Circulation 90:I-205, 1994.
Pracyk JB, Wall TC, Longabaugh JP, Tice FD, Hochrein J, Green C, Cox G, Lee K, Stack RS, Tcheng JE. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998 Apr 15;81(8):970-6. doi: 10.1016/s0002-9149(98)00074-5. PubMed 9576155 ↗
Resar JR, Prewitt KC, Wolff MR, Blumenthal R, Raqueno JV, Brinker JA. Percutaneous transluminal coronary angioplasty through 6F diagnostic catheters: a feasibility study. Am Heart J. 1993 Jun;125(6):1591-6. doi: 10.1016/0002-8703(93)90745-u. PubMed 8498298 ↗
Cragg AH, Nakagawa N, Smith TP, Berbaum KS. Hematoma formation after diagnostic angiography: effect of catheter size. J Vasc Interv Radiol. 1991 May;2(2):231-3. doi: 10.1016/s1051-0443(91)72287-2. PubMed 1799761 ↗
Waksman R, King SB 3rd, Douglas JS, Shen Y, Ewing H, Mueller L, Ghazzal ZM, Weintraub WS. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol. 1995 May 1;75(14):886-9. doi: 10.1016/s0002-9149(99)80681-x. PubMed 7732995 ↗
Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103. PubMed 2912567 ↗
Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol. 1997 May;29(6):1269-75. doi: 10.1016/s0735-1097(97)00064-8. PubMed 9137223 ↗
Bertrand ME, Legrand V, Boland J, Fleck E, Bonnier J, Emmanuelson H, Vrolix M, Missault L, Chierchia S, Casaccia M, Niccoli L, Oto A, White C, Webb-Peploe M, Van Belle E, McFadden EP. Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study. Circulation. 1998 Oct 20;98(16):1597-603. doi: 10.1161/01.cir.98.16.1597. PubMed 9778323 ↗
Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998 Dec 3;339(23):1665-71. doi: 10.1056/NEJM199812033392303. PubMed 9834303 ↗
Dick RJ, Popma JJ, Muller DW, Burek KA, Topol EJ. In-hospital costs associated with new percutaneous coronary devices. Am J Cardiol. 1991 Oct 1;68(9):879-85. doi: 10.1016/0002-9149(91)90403-8. PubMed 1927947 ↗
Krause PB, Klein LW. Utility of a percutaneous collagen hemostasis device: to plug or not to plug? J Am Coll Cardiol. 1993 Nov 1;22(5):1280-2. doi: 10.1016/0735-1097(93)90530-e. No abstract available. PubMed 8227780 ↗
Anderson HV, Bertrand M, Whitworth HB, Sax FL, Willerson JT for the Restore Investigators. Bleeding risk with platelet inhibition using Tirofiban: The Restore Trial. Circulation. 94:I-553, 1996.
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.
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.
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.
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. PubMed 9258477 ↗
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. PubMed 9422835 ↗
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. PubMed 9453535 ↗
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. PubMed 12847195 ↗
Duffin DC, Muhlestein JB, Allisson SB, Horne BD, Fowles RE, Sorensen SG, Revenaugh JR, Bair TL, Lappe DL. Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invasive Cardiol. 2001 May;13(5):354-62. PubMed 11385148 ↗
Shammas NW, Rajendran VR, Alldredge SG, Witcik WJ, Robken JA, Lewis JR, McKinney D, Hansen CA, Kabel ME, Harris M, Jerin MJ, Bontu PR, Dippel EJ, Labroo A. Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty. Catheter Cardiovasc Interv. 2002 Apr;55(4):421-5. doi: 10.1002/ccd.10098. PubMed 11948884 ↗
Ward SR, Casale P, Raymond R, Kussmaul WG 3rd, Simpfendorfer C. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Angio-Seal Investigators. Am J Cardiol. 1998 Mar 1;81(5):569-72. doi: 10.1016/s0002-9149(97)00970-3. PubMed 9514451 ↗
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. PubMed 7759724 ↗
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. PubMed 11249907 ↗
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. PubMed 22162141 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00736086
Lead sponsor: Abbott Medical Devices
First posted: Aug 15, 2008
Start date: Mar 2006
Primary completion: Nov 2006
Completion: Dec 2006
Last update: Aug 15, 2008

Study contacts

William Kussmaul, MD

principal investigator · Drexel University/Hahnemann

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Abbott Medical Devices

Start the discussion