Recruitment

Recruitment Status
Completed
Estimated Enrollment
10

Inclusion Criterias

Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
Over 18 years of age.
Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
...
Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
Over 18 years of age.
Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
Each patient, or his or her guardian or legal representative, is willing to give informed consent.

Summary

Conditions
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the i...

This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number. Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment. Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee. This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site. This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee (DSMC) will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups.

Inclusion Criterias

Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
Over 18 years of age.
Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
...
Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
Over 18 years of age.
Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.
Each patient, or his or her guardian or legal representative, is willing to give informed consent.

Locations

Dublin
Dublin

Tracking Information

NCT #
NCT01943344
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dr Peter Crean, FRCPI MB ChB St Jame's Hospital, Dublin
  • Dr Peter Crean, FRCPI MB ChB St Jame's Hospital, Dublin