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Star-Close Versus Angio-Seal for Femoral Artery Hemostasis (CLOSE)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590356
First Posted: January 10, 2008
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
  Purpose
This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).

Condition Intervention Phase
Percutaneous Intervention Via Femoral Artery Device: StarClose® Device: AngioSeal® Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Percutaneous CLip-based Vascular Occluder (Star-Close) Versus Bio-absorble Hemostatic Device (Angio-SEal) for Femoral Artery Hemostasis After Percutaneous Coronary Intervention

Further study details as provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Composite of major vascular complications necessitating surgical or percutaneous repair. [ Time Frame: 30-days after randomization ]

Secondary Outcome Measures:
  • The time to hemostasis. [ Time Frame: 30-days after treatment ]
  • Procedure time. [ Time Frame: 30-days after treatment ]
  • Device success. [ Time Frame: 30-days after treatment ]
  • Procedure success. [ Time Frame: 30-days after treatment ]
  • Time to ambulation. [ Time Frame: 30-days after treatment ]
  • Time to discharge. [ Time Frame: 30-days after treatment ]
  • Subject's comfort level during the deployment of the StarClose using the 11-point Box Scale (BS-11). [ Time Frame: 30-days after treatment ]

Enrollment: 0
Study Start Date: March 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A2
AngioSeal®
Device: AngioSeal®
Closure device for femoral artery suture site occlusion
Experimental: A1
StarClose®
Device: StarClose®
Closure device for femoral artery suture site occlusion
Other Name: StarClose® vs. AngioSeal®

Detailed Description:

The growing success of interventions and requirement for day case or outpatient procedures has led to a concomitant rise in the use of arteriotomy closure devices (ACD) to achieve hemostasis and allow early mobilization following arterial punctures. ACD have emerged as an alternative to traditional mechanical compression after percutaneous coronary intervention (PCI). When compared to manual compression, several studies have confirmed patient comfort, reduced time to achieve hemostasis, reduced time to ambulation, and early discharge.

Recently, CLIP Trial was conducted to evaluated the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n=113), diagnostic (n=208), and interventional (n=275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. This trial demonstrated that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

However, there are no studies randomly comparing these two closure devices. Therefore, this study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must be at least 18 years of age.
  • Patients with appropriate arterial puncture in the common femoral artery eligible for percutaneous closure device deployment Patients undergoing PCI (only 7F sheath)
  • Patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • Uncontrolled hypertension
  • Severe peripheral vascular disease
  • Severe femoral artery tortousity and calcification
  • Severe obesity (BMI > 35)
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  • Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  • Patients with cardiogenic shock
  • Acute MI patients within symptom onset < 12 hours needing primary angioplasty
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590356


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

Responsible Party: Seung-Jung Park, professor, Division of Cardiology, Department of Internal Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT00590356     History of Changes
Other Study ID Numbers: 20070208
First Submitted: December 31, 2007
First Posted: January 10, 2008
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
Device closure

Additional relevant MeSH terms:
Hemostatics
Coagulants