Prospective Registry on Vascular Access in Interventions in Lazio Region (PREVAIL)
This study has been completed.
Sponsor:
San Filippo Neri General Hospital
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT00674778
First received: May 5, 2008
Last updated: May 7, 2008
Last verified: May 2008
| Tracking Information | |||||
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| First Received Date ICMJE | May 5, 2008 | ||||
| Last Updated Date | May 7, 2008 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00674778 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction [ Time Frame: in-hospital ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prospective Registry on Vascular Access in Interventions in Lazio Region | ||||
| Official Title ICMJE | Prospective Registry on Vascular Access in Interventions in Lazio Region | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Postoperative Hemorrhages | ||||
| Intervention ICMJE | Procedure: Any percutaneous cardiovascular procedure | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1052 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00674778 | ||||
| Other Study ID Numbers ICMJE | 1/6/2006 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Christian Pristipino, MD, San Filippo Neri Hospital | ||||
| Study Sponsor ICMJE | San Filippo Neri General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | San Filippo Neri General Hospital | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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