Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter

NCT ID: NCT01327365

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sheathless group

patient randomized to the sheathless guiding catheter group

Group Type: EXPERIMENTAL

trans-radial PCI (TRI)

Intervention Type: PROCEDURE

TRI performed using the sheathless guiding approach

Conventional group

patients randomized to the conventional guiding catheter group

Group Type: ACTIVE_COMPARATOR

trans-radial PCI (TRI)

Intervention Type: PROCEDURE

TRI performed using a conventional guiding approach

Interventions

trans-radial PCI (TRI)

TRI performed using the sheathless guiding approach

Intervention Type: PROCEDURE

trans-radial PCI (TRI)

TRI performed using a conventional guiding approach

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Robert F Bonvini

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University hospital

Geneva, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Robert F Bonvini, MD

Role: primary

robert.bonvini@hcuge.ch

0041 22 372 72 00

References

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.

Reference Type: BACKGROUND

PMID: 18727126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20049959 (View on PubMed)

Related Links

http://www.hug-ge.ch

geneva university hospital web site

Other Identifiers

Sheathless-TRI

Identifier Type: -

Identifier Source: org_study_id