A Phase 2 interventional study of trans-radial PCI (TRI) and trans-radial PCI (TRI) in Coronary Artery Disease, sponsored by University Hospital, Geneva. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-06.
Sponsored by University Hospital, Geneva · Phase 2, Interventional, and Treatment
Background:
The transradial approach is increasingly used in percutaneous coronary intervention (PCI) because of lower major access site complications, lower bleeding risk and earlier patient mobilization. According to this trend, in the last couple of years at the University Hospital of Geneva the investigators have changed their practice and currently the transradial approach is the most frequently used for PCI. However, the small diameter of the radial artery remains a major limitation of the technique, especially in women or for complex PCI necessitating larger bore guiding catheters. This may be overcome with sheathless guiding catheters (Asahi, Japan), allowing for a standard inner catheter diameter (6-7 Fr), with an outer diameter equivalent to a standard 5 and 6 Fr introducer sheath.
Aim:
This study is aimed to compare the transradial approach for PCI with a sheathless guiding catheter and with a standard guiding catheter in women and patients with complex lesion necessitating large bore guiding catheters.
Material and methods:
This prospective study will consecutively randomize all women and all men with bifurcation/ostial lesion of a major coronary vessel (i.e. ≈ 120/year) in whom a transradial PCI is attempted. The procedures will be performed either with a standard 6 or 7Fr guiding catheter or with the sheathless 6.5, 7.5 Fr catheters.
End-points:
Successful performance a transradial PCI in all consecutive patients which qualify according to the inclusion criteria (technical feasibility). Establish the proportion of procedures performed with no device-related complications (safety). Analyze in details the technical aspects of the sheathless catheter (efficacy).
Sample size:
The investigators have planed to include in the study ≈ 250 patients in two years. After 1 year of enrollment the investigators will perform an interim analysis and the instigators will decide at that moment, according to the observed end-points, if prolonging the study would be of any scientific value. In this case another 100 patients will be further included in the study.
Enrollment time:
The investigators will start the study as soon the local ethical committee will give us the permission. The investigators plan to start the study in July 2010. The end is expected for July 2012.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 250 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in whom the radial approach is contra-indicated:
Patients in whom the femoral approach is adopted as primary catheterization approach (at interventionist's discretion), including:
patient randomized to the sheathless guiding catheter group
Procedure: trans-radial PCI (TRI)
patients randomized to the conventional guiding catheter group
Procedure: trans-radial PCI (TRI)
TRI performed using the sheathless guiding approach
TRI performed using a conventional guiding approach
Procedural success
Procedural success, defined as a successful delivery of the stent using the sheathless guding catheter, in consecutive patients according to the inclusion criteria (women and bifurcation/ostial lesions) = technical feasibility of the sheathless catheter.
Time frame: baseline
Procedural safety
Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
Time frame: baseline
Procedural safety
Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
Time frame: +24 hours
Safety and Tolerability
Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
Time frame: baseline
safety and tolerability
Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
Time frame: +24 hours
This study is status unknown, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Geneva