Coronary Artery DiseasePhase 2Sheathless-TRINCT01327365
Trans-Radial Coronary Interventions Using A Sheathless Guiding Catheter
A Phase 2 study testing trans-radial PCI (TRI) in people with Coronary Artery Disease, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- trans-radial PCI (TRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2010to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University hospital
Geneva, Canton of Geneva, 1211
Robert F Bonvini, MD, 0041 22 372 72 00, robert.bonvini@hcuge.ch
Robert F Bonvini, MD
About this study
Official title: 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.
Read more
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
- Being tested
- trans-radial PCI (TRI)
- Keywords
- significant coronary artery disease, PCI, radial approach, women, bifurcation lesion, ostial lesion, 7 Fr guiding catheter, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-radial PCI (TRI)Procedure or surgery
TRI performed using the sheathless guiding approach
trans-radial PCI (TRI)Procedure or surgery
TRI performed using a conventional guiding approach
| Study group | Role | What they receive |
|---|---|---|
| Sheathless group | Experimental | patient randomized to the sheathless guiding catheter group Receives: Procedure: trans-radial PCI (TRI) |
| Conventional group | Active comparator | patients randomized to the conventional guiding catheter group Receives: Procedure: trans-radial PCI (TRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Procedural safety
Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
Measured: baseline
Procedural safety
Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
Measured: +24 hours
Secondary outcomes (2)
Safety and Tolerability
Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
Measured: baseline
safety and tolerability
Analyze the technical aspect of the sheathless catheter, in term of the number of Participants with Adverse Events
Measured: +24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert F Bonvini, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327365
- Sponsor's protocol ID
- Sheathless-TRI
- Acronym
- Sheathless-TRI
- Status last verified
- Mar 2013
- First submitted
- 23 Aug 2010
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18727126Mamas 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.
PubMed 20049959
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Radial Percutaneous Coronary Interventions Using a Sheathless Guiding Catheter-Based Approach
- ClinicalTrials.gov ID
- NCT01327365
- Acronym / sponsor ID
- Sheathless-TRI / Sheathless-TRI
- Conditions
- Coronary Artery Disease
- Keywords
- significant coronary artery disease, PCI, radial approach, women, bifurcation lesion, ostial lesion, 7 Fr guiding catheter, percutaneous coronary intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (estimated)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sheathless group | Experimental | Procedure: trans-radial PCI (TRI)patient randomized to the sheathless guiding catheter group |
| Conventional group | Active comparator | Procedure: trans-radial PCI (TRI)patients randomized to the conventional guiding catheter group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 listed)
- 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:
- Challenging vessel anatomy,
- Vessel tortuosity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trans-radial PCI (TRI)TRI performed using the sheathless guiding approach | Procedure or surgery | Sheathless group |
| trans-radial PCI (TRI)TRI performed using a conventional guiding approach | Procedure or surgery | Conventional group |
Primary outcome
Procedural success
Time frame: baseline
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
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
Procedural safety, defined as the proportion of procedures performed in the absence of device-related complications (= safety of the sheathless catheter).
2 secondary outcomes
Safety and Tolerability
Time frame: baseline
safety and tolerability
Time frame: +24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 18727126Mamas 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.
- Background: PubMed 20049959Mamas 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.
- geneva university hospital web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trans-radial PCI (TRI) in people with Coronary Artery Disease, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.