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

This study has been completed.
Sponsor:
Information provided by:
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00736086
First received: August 13, 2008
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Peripheral Vascular Disease
Cardiovascular Disease
Device: Vessel Closure (StarClose™)
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose™ Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Enrollment: 165
Study Start Date: March 2006
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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™)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion:

  • 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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736086

Locations
United States, California
Scripps Memorial Hospital
La Jolla, California, United States, 92037
United States, Georgia
Fuqua Heart Center/ Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Heart Care Midwest (OSF/St Francis)
Peoria, Illinois, United States, 61603
United States, Indiana
The Care Group LLC (St. Vincent's Hospital)
Indianapolis, Indiana, United States, 46260
United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
United States, Minnesota
Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Buffalo Heart group
Buffalo, New York, United States, 14203
United States, Ohio
North Ohio Research LTD Elyria Regional Medical
Elyria, Ohio, United States, 44035
United States, Pennsylvania
Drexel University College of Medicine Hahnemann
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: William Kussmaul, MD Drexel University/Hahnemann
  More Information

Publications:
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boris Jelecic, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00736086     History of Changes
Other Study ID Numbers: AVD-640-0057
Study First Received: August 13, 2008
Last Updated: August 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Vascular:
femoral artery
post-percutaneous cardiac catheterization
post-percutaneous peripheral vascular catheterization
post-percutaneous diagnostic catheterization
early ambulation
vascular closure

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis

ClinicalTrials.gov processed this record on November 20, 2014