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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00590356
First received: December 31, 2007
Last updated: August 18, 2010
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 CardioVascular Research Foundation, Korea:

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

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

Estimated Enrollment: 532
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590356

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
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

No publications provided

Responsible Party: Seung-Jung Park, MD, PhD, CardioVascular Research Foundation
ClinicalTrials.gov Identifier: NCT00590356     History of Changes
Other Study ID Numbers: 20070208
Study First Received: December 31, 2007
Last Updated: August 18, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Device closure

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014