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Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography (CLOSE-UP I)

This study has been completed.
Sponsor:
Collaborator:
Vingmed Danmark A/S
Information provided by:
Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01001663
First received: October 16, 2009
Last updated: November 9, 2010
Last verified: October 2009
History of Changes
  Purpose

Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?


Condition Intervention Phase
Coronary Angiography Via Femoral Artery Access
 Device: FemoSeal®
Other: Manual compression
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. [ Time Frame: 20 minutes, 1 hour and at discharge, pooled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics . [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Time to hemostasis, from sheath removal to hemostasis is achieved [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Time from end of closure procedure to ambulation. 1h bedrest recommended. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Device deployment failure [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Time to cessation of continuous minor oozing measured from the end of the closure procedure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Need for repeated manual compression after end of the closure procedure [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: 20 min ] [ Designated as safety issue: No ]
  • Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids) [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • The patient seeking medical assistance for all-cause closure site related symptoms after discharge. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 1005
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FemoSeal® Device: FemoSeal®
Closure device for femoral artery access closure
Active Comparator: Manual compression Other: Manual compression
Conventional manual compression

Detailed Description:

Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.

  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 old
  • Patients undergoing femoral access coronary angiography
  • Patient must be competent for providing informed, written consent
  • Only 6F sheath

Exclusion Criteria:

  • Percutaneous coronary intervention
  • Intra coronary measurements (FFR, IVUS, OCT, NIR)
  • Groin hematoma before closure
  • Pseudoaneurysm or AV fistula
  • Significant stenosis of ilial or femoral artery
  • Prior peripheral artery surgery
  • INR > 3,0
  • Platelet count < 120 million per millilitre blood
  • Coagulopathy (bleeding disorder)
  • Thrombolysis in the last 24h
  • Planned heparin infusion after the procedure
  • Pregnancy
  • Uncontrolled hypertension > 200 mmHg / 110 mmHg
  • Femoral access device closure in the last 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001663

Locations
Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
Skejby Hospital
Vingmed Danmark A/S
Investigators
Principal Investigator: Niels R. Holm, MD Skejby Hospital
  More Information

No publications provided

Responsible Party: Niels R. Holm MD, PI, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01001663     History of Changes
Other Study ID Numbers: M-20090101
Study First Received: October 16, 2009
Last Updated: November 9, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on May 22, 2013