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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

trans-radial PCI (TRI)

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring significant coronary artery disease, PCI, radial approach, women, bifurcation lesion, ostial lesion, 7 Fr guiding catheter, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sheathless group

Conventional group

Arm Description

patient randomized to the sheathless guiding catheter group

patients randomized to the conventional guiding catheter group

Outcomes

Primary Outcome Measures

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.

Procedural safety

Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).

Procedural safety

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

Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events

safety and tolerability

Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events

Full Information

NCT ID

NCT01327365

First Posted

August 23, 2010

Last Updated

March 5, 2013

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT01327365

Brief Title

Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter

Acronym

Sheathless-TRI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2010 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Geneva

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

significant coronary artery disease, PCI, radial approach, women, bifurcation lesion, ostial lesion, 7 Fr guiding catheter, percutaneous coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sheathless group

Arm Type

Experimental

Arm Description

patient randomized to the sheathless guiding catheter group

Arm Title

Conventional group

Arm Type

Active Comparator

Arm Description

patients randomized to the conventional guiding catheter group

Intervention Type

Procedure

Intervention Name(s)

trans-radial PCI (TRI)

Intervention Description

TRI performed using the sheathless guiding approach

Intervention Type

Procedure

Intervention Name(s)

trans-radial PCI (TRI)

Intervention Description

TRI performed using a conventional guiding approach

Primary Outcome Measure Information:

Title

Procedural success

Description

Time Frame

baseline

Title

Procedural safety

Description

Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).

Time Frame

baseline

Title

Procedural safety

Description

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

Secondary Outcome Measure Information:

Title

Safety and Tolerability

Description

Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events

Time Frame

baseline

Title

safety and tolerability

Description

Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events

Time Frame

+24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

University hospital

City

Geneva

State/Province

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert F Bonvini, MD

Phone

0041 22 372 72 00

robert.bonvini@hcuge.ch

First Name & Middle Initial & Last Name & Degree

Robert F Bonvini, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

18727126

Citation

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.

Results Reference

background

PubMed Identifier

20049959

Citation

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.

Results Reference

background

Links:

URL

http://www.hug-ge.ch

Description

geneva university hospital web site

Learn more about this trial

Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter

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