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 (Responsible Party):
Niels Ramsing Holm, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01001663
First received: October 16, 2009
Last updated: September 5, 2013
Last verified: September 2013
  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 Aarhus University Hospital Skejby:

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: Yes ]
  • Device deployment failure [ Time Frame: 20 minutes ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: Discharge ] [ Designated as safety issue: Yes ]
  • Pain and discomfort measured on a numerical pain rating scale (0-10) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

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®
Closure device for femoral artery access closure
Device: FemoSeal®
Closure device for femoral artery access closure
Active Comparator: Manual compression
Conventional 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
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: NCT01001663

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

No publications provided

Responsible Party: Niels Ramsing Holm, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01001663     History of Changes
Other Study ID Numbers: M-20090101
Study First Received: October 16, 2009
Last Updated: September 5, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital Skejby:
CAG

ClinicalTrials.gov processed this record on October 21, 2014