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

Aarhus University Hospital Skejby818 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

818

Conditions

Coronary Disease

Interventions

Exoseal closure deviceDEVICE

Closure device for femoral artery access closure

Angioseal closure deviceDEVICE

Closure device for femoral artery access closure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital

Aarhus N, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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

Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days

Device failure

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

Vasovagal reaction until 5 minutes after end of closure procedure

Time frame: 30 minuts

Need for new onset of manual compression

Time frame: 30 days

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

Data from ClinicalTrials.gov

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