Prospective Registry on Vascular Access in Interventions in Lazio Region (PREVAIL)

San Filippo Neri General Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Hemorrhages

Treatments: Procedure: Any percutaneous cardiovascular procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT00674778

1/6/2006

Details and patient eligibility

About

Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.

We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.

Enrollment: 1,052 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing any percutaneous cardiovascular procedure

Exclusion criteria

• Patients already enrolled in other clinical trials

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,052 participants in 2 patient groups

1

Experimental group

Description:

Radial approach

Treatment:

Procedure: Any percutaneous cardiovascular procedure

2

Active Comparator group

Description:

Femoral approach

Treatment:

Procedure: Any percutaneous cardiovascular procedure