ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (CLOSE-UP III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02237430
Recruitment Status : Active, not recruiting
First Posted : September 11, 2014
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Vingmed Danmark A/S
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: MynxGrip Other: Manual compression Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 869 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 16, 2014
Actual Primary Completion Date : May 16, 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Manuel compression
Conventional manual compression
Other: Manual compression
Conventional manual compression

Experimental: MynxGrip closure device
Closure device for femoral artery access closure
Device: MynxGrip
Closure device for femoral artery access closure
Other Name: Closure device




Primary Outcome Measures :
  1. Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) [ Time Frame: 30 days ]
    This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.


Secondary Outcome Measures :
  1. Time (min) to haemostasis [ Time Frame: 30 days ]
    From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis

  2. Device failure [ Time Frame: 30 minutes ]
  3. Vasovagal reaction until 5 minutes after end of closure procedure [ Time Frame: 30 minutes ]
  4. Need for new onset of manual compression [ Time Frame: 30 days ]
  5. Pain and discomfort related to the closure procedure [ Time Frame: Closure procedure and 30 days ]
    Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort).

  6. Time to mobilization [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days ]
    From start of closure procedure to patient is mobilised.

  7. In-hospital large groin haematoma [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days ]
    Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge

  8. Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions [ Time Frame: 1 hour and 30 days ]
  9. Major bleeding and/or bleeding necessitation blood transfusion [ Time Frame: 30 days and 6 months ]
  10. Pseudoaneurysm with indication for treatment [ Time Frame: 30 days and 6 months ]
  11. Arteriovenous fistula [ Time Frame: 30 days and 6 months ]
  12. Groin surgery and/or possible related vascular surgery [ Time Frame: 30 days and 6 months ]
  13. Infection needing antibiotics [ Time Frame: 30 days and 6 months ]
  14. Need for medical evaluation of possible closure procedure related symptom(s) [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237430


Locations
Denmark
Aarhus University Hospital
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
Vingmed Danmark A/S
Investigators
Principal Investigator: Evald H Christiansen, MD Aarhus University Hospital

Responsible Party: Evald Hoej Christiansen, MD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02237430     History of Changes
Other Study ID Numbers: CLOSE-UP III
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Evald Hoej Christiansen, Aarhus University Hospital Skejby:
Coronary angiography (CAG)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases