MedDataX Logo

Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography

NCT ID: NCT01001663

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1005 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Angiography Via Femoral Artery Access

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CAG

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FemoSeal®

Closure device for femoral artery access closure

Group Type EXPERIMENTAL

FemoSeal®

Intervention Type DEVICE

Closure device for femoral artery access closure

Manual compression

Conventional manual compression

Group Type ACTIVE_COMPARATOR

Manual compression

Intervention Type OTHER

Conventional manual compression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FemoSeal®

Closure device for femoral artery access closure

Intervention Type DEVICE

Manual compression

Conventional manual compression

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vingmed Danmark A/S

INDIV

Sponsor Role collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Niels Ramsing Holm

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Niels R. Holm, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital Skejby

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aarhus University Hospital Skejby

Aarhus N, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24603054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23532433 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M-20090101

Identifier Type: -

Identifier Source: org_study_id