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

Effectiveness and safety of three percutaneous arterial closure devices (collagen plug, metallic clip and suture mediated) compared to manual compression in hemostasis after percutaneous transfemoral arterial procedures in peripheral territories

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55240225

Enrollment

Registered

2017-08-01

Start date

2012-06-01

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease Circulatory System Peripheral vascular disease, unspecified

Interventions

Patients are assigned randomly, by means of a computer generated number, at the end of the procedure to receive hemostasis of the femoral arterial access site with one of the three arterial closure de

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Spain

Contacts

Public ContactJavier Peinado Cebrián

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026