Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial

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

NA

Total Enrollment

869 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-16

Study Completion Date

2018-12-16

Brief Summary

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

Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure

NCT02438475

Cardiac Diagnostic Procedure Cardiac Interventional Procedure Femoral Access Site Closure

COMPLETED PHASE4

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

NCT01001663

Coronary Angiography Via Femoral Artery Access

COMPLETED PHASE4

Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device

NCT00842179

Vascular Closure

COMPLETED

Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression

NCT05554471

Venous Vascular Closure

COMPLETED NA

Mobilization and Outcomes After Venous Closure

NCT07246902

Venous Vascular Closure Electrophysiology Study

RECRUITING

Detailed Description

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

Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.

Conditions

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

Coronary Disease

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.

Manuel compression

Conventional manual compression

Group Type ACTIVE_COMPARATOR

Manual compression

Intervention Type OTHER

Conventional manual compression

MynxGrip closure device

Closure device for femoral artery access closure

Group Type EXPERIMENTAL

MynxGrip

Intervention Type DEVICE

Closure device for femoral artery access closure

Interventions

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

MynxGrip

Closure device for femoral artery access closure

Intervention Type DEVICE

Manual compression

Conventional manual compression

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Closure device

Eligibility Criteria

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

Inclusion Criteria

* \>18 year
* Should be able to provide valid informed signed consent
* CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)

Exclusion Criteria

* Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
* ST-Elevations Myocardial Infarction (STEMI)
* Multiple punctures
* Active infection
* Groin haematoma before the closure procedure
* Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
* Cardiogenic shock
* Prior peripheral arterial surgery in abdomen or lower extremities
* Sheat size \>7 F
* Life expectancy less than one year
* Possible pregnancy or positive pregnancy test or breastfeeding women
* Simultaneous or planned subsequent femoral vein access
* Allergy to any of the components in the closure material left in the groin
* Puncture or closure with closure device at same site \< 30 days
* Puncture or closure with manuel compression at same site \< 5 days
* Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No