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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Robert F Bonvini, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01327365
First received: August 23, 2010
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: trans-radial PCI (TRI)
Phase 2

Study Type: Interventional
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

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 250
Study Start Date: August 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327365

Locations
Switzerland
University hospital Recruiting
Geneva, GE, Switzerland, 1211
Contact: Robert F Bonvini, MD    0041 22 372 72 00    robert.bonvini@hcuge.ch   
Principal Investigator: Robert F Bonvini, MD         
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Additional Information:
Publications:
Responsible Party: Robert F Bonvini, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01327365     History of Changes
Other Study ID Numbers: Sheathless-TRI
Study First Received: August 23, 2010
Last Updated: March 5, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
significant coronary artery disease
PCI
radial approach
women
bifurcation lesion
ostial lesion
7 Fr guiding catheter
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014