Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter (Sheathless-TRI)

Trans-Radial Percutaneous Coronary Interventions Using a Sheathless Guiding Catheter-Based Approach

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: trans-radial PCI (TRI); Procedure: trans-radial PCI (TRI)

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • Recruiting
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients need to be at least 18 years old.
• Patients presenting with a significant coronary artery disease who qualify for PCI and who can be treated by a radial approach.
• Any women requiring PCI who can be treated by a radial approach.
• Any patients with a bifurcation lesion or the ostial lesion of the left anterior descending (LAD) and/or left circumflex artery (LCX), lesions commonly treated with a 7 Fr guiding catheter.
• Bifurcation lesion = any lesion of a main epicardial vessel (i.e. LAD, LCX, right coronary artery) involving at least one major side branch (i.e. diagonal or marginal branches).
• Ostial lesion of the LAD or LCX = presence of a significant stenosis <5mm from the distal part of the left main.

Exclusion Criteria:

• Patients who refused to give their written informed consent.
• Male patients, in whom PCI can be easily performed with a 6 Fr standard guiding catheter (i.e. no bifurcation or ostial lesion).

• Patients in whom the radial approach is contra-indicated:

  • Patients with a dialysis arteria-venous fistula or in whom an arteria-venous fistula is planed in the future.
  • Patients with a known radial artery occlusion.
  • Patients in whom a radial approach was unsuccessfully already attempted in the past (anamnestic notion or previous medical record) secondary to a:
• Challenging vessel anatomy,
• Vessel tortuosity,
• Known impossibility to cannulate the coronary ostia by the radial approach.
• Patients in whom the Allen test results pathological bilaterally:
• In case of pathological Allen test in one hand the other hand will be tested before choosing the femoral approach.

• Patients in whom the femoral approach is adopted as primary catheterization approach (at interventionist's discretion), including:

  • Unstable patients (myocardial infarction, cardiogenic shock).
  • Patients necessitating femoral access for an intra-aortic balloon counterpulsation
  • Patients presenting with a double mammary coronary graft (right and left internal mammary utilized for by-pass grafts).
• Coronary interventions where an extreme good guiding support is mandatory (i.e. PCI of chronic total occlusion, PCI with Rotablator).
• Particularly risky PCI (e.g., PCI of the left main artery), where the femoral approach may be more comfortable for the operator.
• Patients requiring a femoral approach for a right heart catheterization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sheathless group; patient randomized to the sheathless guiding catheter group	Procedure: trans-radial PCI (TRI); TRI performed using the sheathless guiding approach; Procedure: trans-radial PCI (TRI); TRI performed using a conventional guiding approach
ACTIVE_COMPARATOR: Conventional group; patients randomized to the conventional guiding catheter group	Procedure: trans-radial PCI (TRI); TRI performed using the sheathless guiding approach; Procedure: trans-radial PCI (TRI); TRI performed using a conventional guiding approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline
Procedural safety	Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).	baseline
Procedural safety	Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).	+24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events	baseline
safety and tolerability	Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events	+24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

General Publications

• Mamas MA, Fath-Ordoubadi F, Fraser DG. Atraumatic complex transradial intervention using large bore sheathless guide catheter. Catheter Cardiovasc Interv. 2008 Sep 1;72(3):357-364. doi: 10.1002/ccd.21637.
• Mamas M, D'Souza S, Hendry C, Ali R, Iles-Smith H, Palmer K, El-Omar M, Fath-Ordoubadi F, Neyses L, Fraser DG. Use of the sheathless guide catheter during routine transradial percutaneous coronary intervention: a feasibility study. Catheter Cardiovasc Interv. 2010 Mar 1;75(4):596-602. doi: 10.1002/ccd.22246.

Helpful Links

• geneva university hospital web site

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (ESTIMATE): April 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 6, 2013
• Last Update Submitted That Met QC Criteria: March 5, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: PCI; percutaneous coronary intervention; women; radial approach; bifurcation lesion; significant coronary artery disease; ostial lesion; 7 Fr guiding catheter
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Sheathless-TRI