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Prospective Registry on Vascular Access in Interventions in Lazio Region

NCT ID: NCT00674778

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1052 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Hemorrhages

Keywords

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Radial Femoral artery Invasive cardiology safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Radial approach

Group Type EXPERIMENTAL

Any percutaneous cardiovascular procedure

Intervention Type PROCEDURE

2

Femoral approach

Group Type ACTIVE_COMPARATOR

Any percutaneous cardiovascular procedure

Intervention Type PROCEDURE

Interventions

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Any percutaneous cardiovascular procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria

* Patients already enrolled in other clinical trials
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Filippo Neri General Hospital

OTHER

Sponsor Role lead

Responsible Party

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San Filippo Neri Hospital

Principal Investigators

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Giuseppe Richichi, MD

Role: STUDY_CHAIR

San Filippo Neri Hospital

Other Identifiers

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1/6/2006

Identifier Type: -

Identifier Source: org_study_id