CClinicalTrials.gg
CompletedNCT00821106TALENTUpdated Mar 19, 2010

Left Versus Right Transradial Approach for Percutaneous Coronary Procedures

An interventional study of Right radial and left radial in Coronary Angiography and Angioplasty, Transluminal, Percutaneous Coronary, sponsored by Policlinico Casilino ASL RMB. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-19.

Sponsored by Policlinico Casilino ASL RMB · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,540
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.

The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.

The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).

Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.

02

Conditions studied

  • Coronary Angiography
  • Angioplasty, Transluminal, Percutaneous Coronary

Keywords

  • Coronary angiography
  • percutaneous coronary intervention
  • Transradial approach
03

In context

Lead sponsor

Policlinico Casilino ASL RMB is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients who undergo to diagnostic or interventional procedures

Exclusion criteria

Exclusion Criteria:

  • Previous coronary artery by-pass
  • Acute myocardial infarction with ST segment elevation myocardial infarction
  • Cardiogenic shock
  • Ischemic Allen Test
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,540 participants (actual)

Study arms

  • Experimental
    Right transradial approach

    Coronary diagnostic or interventional procedures performed through right radial approach

    Procedure: Right radial

  • Experimental
    Left transradial approach

    Diagnostic or interventional procedures performed through left radial approach

    Procedure: left radial

Interventions

  • ProcedureRight radial

    diagnostic or interventional procedures performed through right transradial approach

  • Procedureleft radial

    diagnostic or interventional procedures performed through left transradial approach

06

What researchers measure

Primary outcomes

  1. Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients

    Time frame: 7 days

Secondary outcomes

  1. Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.

    Time frame: 7 days

07

Study locations

2 sites
  • Policlinico Casilino-ASL RMB
    Rome, Italy
  • Università Cattolica del Sacro Cuore
    Rome, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00821106
Lead sponsor
Policlinico Casilino ASL RMB
First posted
Jan 13, 2009
Start date
Jan 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 19, 2010

Study contacts

Alessandro Sciahbasi, MD
principal investigator · Policlinico Casilino ASL RMB

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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