NCT01001663

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

October 16, 2009

Last Update Submit

December 29, 2025

Conditions

Coronary Angiography Via Femoral Artery Access

Keywords

CAG

Outcome Measures

Primary Outcomes (1)

  • Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.

    20 minutes, 1 hour and at discharge, pooled

Secondary Outcomes (13)

  • Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.

    14 days

  • Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .

    14 days

  • Time to hemostasis, from sheath removal to hemostasis is achieved

    14 days

  • Time from end of closure procedure to ambulation. 1h bedrest recommended.

    14 days

  • Device deployment failure

    20 minutes

  • +8 more secondary outcomes

Study Arms (2)

FemoSeal®

EXPERIMENTAL

Closure device for femoral artery access closure

Device: FemoSeal®

Manual compression

ACTIVE COMPARATOR

Conventional manual compression

Other: Manual compression

Interventions

FemoSeal®DEVICE

Closure device for femoral artery access closure

FemoSeal®
Manual compressionOTHER

Conventional manual compression

Manual compression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (2)

  • Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell LR, Hjort J, Thuesen L, Terkelsen CJ, Christiansen EH, Botker HE, Kristensen SD, Lassen JF; CLOSE-UP study group. Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. EuroIntervention. 2014 Jun;10(2):183-90. doi: 10.4244/EIJV10I2A31.

    PMID: 24603054DERIVED

  • Sindberg B, Schou M, Hansen L, Christiansen KJ, Jorgensen KS, Soltoft M, Holm NR, Maeng M, Kristensen SD, Lassen JF. Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study. Eur J Cardiovasc Nurs. 2014 Jun;13(3):221-6. doi: 10.1177/1474515113482809. Epub 2013 Mar 25.

    PMID: 23532433DERIVED

Study Officials

  • Niels R. Holm, MD

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 26, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(1)