Randomized trial comparing effectiveness and safety of three percutaneous arterial closure devices vs manual compression in peripheral interventions

Not Applicable

Completed

• Conditions: Peripheral arterial disease; Peripheral vascular disease, unspecified; Circulatory System

• Registration Number: ISRCTN55240225
• Lead Sponsor: Hospital Virgen de la Salud de Toledo

Brief Summary

2018 results in https://doi.org/10.1016/j.angio.2018.06.005 (added 14/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-06-30
• Study Start: 2017-08-01
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients intervened percutaneously for treatment or diagnostic of peripheral arterial disease through femoral access in the Department of Angiology and Vascular Surgery of the Hospital Virgen de la Salud de Toledo
2. Aged over 18

Exclusion Criteria

1. Known contraindications for any of the percutaneous arterial closure devices tested
2. Deny of the patient to sign the informed consent document

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of the hemostatic procedure applied, assessed by observation of the absence of bleeding through the puncture site immediately after the application of the hemostatic system, 24 hours later and 1 month later

Secondary Outcome Measures

Name	Time	Method
Occurrence of complications related to arterial access site, assessed by postprocedure physical examination, echo doppler at the arterial access, and blood test at 24 hours and 1 month post intervention