Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter (Sheathless-TRI)
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.
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.
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).
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Trans-Radial Percutaneous Coronary Interventions Using a Sheathless Guiding Catheter-Based Approach|
- Procedural success [ Time Frame: baseline ] [ Designated as safety issue: No ]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.
- Procedural safety [ Time Frame: baseline ] [ Designated as safety issue: Yes ]Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
- Procedural safety [ Time Frame: +24 hours ] [ Designated as safety issue: Yes ]Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
- Safety and Tolerability [ Time Frame: baseline ] [ Designated as safety issue: No ]Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
- safety and tolerability [ Time Frame: +24 hours ] [ Designated as safety issue: No ]Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Sheathless group
patient randomized to the sheathless guiding catheter group
Procedure: trans-radial PCI (TRI)
TRI performed using the sheathless guiding approach
Active Comparator: Conventional group
patients randomized to the conventional guiding catheter group
Procedure: trans-radial PCI (TRI)
TRI performed using a conventional guiding approach
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327365
|Geneva, GE, Switzerland, 1211|
|Contact: Robert F Bonvini, MD 0041 22 372 72 00 firstname.lastname@example.org|
|Principal Investigator: Robert F Bonvini, MD|