Prospective Registry on Vascular Access in Interventions... | NCT00674778

Studies
Prospective Registry on Vascular Access in Interventions in Lazio Region

NCT00674778

Sponsor

San Filippo Neri General Hospital

Status

Completed

Last Update Posted

May 8, 2008Estimated

Enrollment

1,052Actual

Phase

Phase 4

Conditions

Postoperative Hemorrhages

Interventions

Any percutaneous cardiovascular procedure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2008

Last Update Posted Date

May 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,052Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Radial approach	Procedure: Any percutaneous cardiovascular procedure
2	Active Comparator	Femoral approach	Procedure: Any percutaneous cardiovascular procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Any percutaneous cardiovascular procedure	Procedure		1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke		in-hospital

Secondary Outcomes

Measure	Description	Time Frame
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction		in-hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria:

Patients already enrolled in other clinical trials

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Giuseppe Richichi, MD	San Filippo Neri Hospital	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D019106	Postoperative Hemorrhage

Ancestor Terms

ID	Term
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided