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Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial (CLOSE-UP II)

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exoseal closure device
Angioseal closure device
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Should be able to provide valid informed signed consent
  • PCI procedure including treatment by balloon and/or stent
  • PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)

Exclusion Criteria:

  • Only coronary angiography
  • Multiple punctures
  • Active infection
  • Groin haematoma before the closure procedure
  • Sheath size > 7 French
  • Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
  • Prior arterial surgery in abdomen and/or lower extremities
  • Cardiogenic shock
  • Life expectancy less than one year
  • The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
  • Simultaneous or planned subsequent femoral vein access
  • Allergy to any of the components in the closure material left in the groin
  • Puncture on same site < 30 days
  • Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD

Sites / Locations

  • Aarhus University Hospital
  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exoseal closure device

Angio-Seal closure device

Arm Description

Closure device for femoral artery access closure

Closure device for femoral artery access closure

Outcomes

Primary Outcome Measures

Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.

Secondary Outcome Measures

Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event
Device failure
Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
Vasovagal reaction until 5 minutes after end of closure procedure
Need for new onset of manual compression
Pain and discomfort related to the closure procedure
Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed
Time to mobilization
From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
In-hospital large groin haematoma
Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge
Bleedings according to the BARC definitions
Access site related and non-access site related
Major bleeding and/or bleeding necessitating blood transfusion
Pseudoaneurysm with indication for treatment
Arteriovenous fistula
Groin surgery and/or possible related vascular surgery
Infection needing antibiotics
Need for medical evaluation of possible closure procedure related symptom(s)

Full Information

First Posted
June 6, 2014
Last Updated
May 31, 2017
Sponsor
Aarhus University Hospital Skejby
Collaborators
Cordis Corporation, Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02234830
Brief Title
Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
Acronym
CLOSE-UP II
Official Title
Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 21, 2012 (Actual)
Primary Completion Date
May 14, 2016 (Actual)
Study Completion Date
May 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Cordis Corporation, Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Detailed Description
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
818 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exoseal closure device
Arm Type
Experimental
Arm Description
Closure device for femoral artery access closure
Arm Title
Angio-Seal closure device
Arm Type
Active Comparator
Arm Description
Closure device for femoral artery access closure
Intervention Type
Device
Intervention Name(s)
Exoseal closure device
Intervention Description
Closure device for femoral artery access closure
Intervention Type
Device
Intervention Name(s)
Angioseal closure device
Intervention Description
Closure device for femoral artery access closure
Primary Outcome Measure Information:
Title
Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
Description
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
Description
Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
Device failure
Description
Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
Time Frame
30 minutes
Title
Vasovagal reaction until 5 minutes after end of closure procedure
Time Frame
30 minuts
Title
Need for new onset of manual compression
Time Frame
30 days
Title
Pain and discomfort related to the closure procedure
Description
Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed
Time Frame
Closure procedure and 30 days
Title
Time to mobilization
Description
From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
In-hospital large groin haematoma
Description
Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 days
Title
Bleedings according to the BARC definitions
Description
Access site related and non-access site related
Time Frame
30 days
Title
Major bleeding and/or bleeding necessitating blood transfusion
Time Frame
6 months
Title
Pseudoaneurysm with indication for treatment
Time Frame
30 days and 6 months
Title
Arteriovenous fistula
Time Frame
30 days and 6 months
Title
Groin surgery and/or possible related vascular surgery
Time Frame
30 days and 6 months
Title
Infection needing antibiotics
Time Frame
30 days and 6 months
Title
Need for medical evaluation of possible closure procedure related symptom(s)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Should be able to provide valid informed signed consent PCI procedure including treatment by balloon and/or stent PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) Exclusion Criteria: Only coronary angiography Multiple punctures Active infection Groin haematoma before the closure procedure Sheath size > 7 French Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin Prior arterial surgery in abdomen and/or lower extremities Cardiogenic shock Life expectancy less than one year The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating Simultaneous or planned subsequent femoral vein access Allergy to any of the components in the closure material left in the groin Puncture on same site < 30 days Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD, PhD
Organizational Affiliation
Arhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial

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