Vascular Access Site OcclusionDISCO COMPLEXNCT05490238
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
A study testing Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) in people with Vascular Access Site Occlusion, run by IGLESIAS Juan Fernando at 9 sites in 5 countries.
Trial summary
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Site Occlusion
- What is being tested?
- Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 31 Aug 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years.
- Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
- Patients planned for PCI of complex coronary lesions, such as CTO, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions in whom the operator anticipates that a 7F guiding catheter is indicated.
- Patients able to provide written informed consent.
Who cannot join
- Patients with acute ST-segment elevation myocardial infarction.
- Patients with cardiogenic shock.
- Patients on chronic hemodialysis.
- Patients with contraindications to TRA, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
- Patients with medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
- Patients unable to provide written informed consent.
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Belgium4 sites, 4 recruiting
- Recruiting
Clinique St. Joseph Arlon - Groupe Vivalia
Arlon
Giuseppe Colletti, MD
- Recruiting
CHU Saint-Pierre
Brussels
Panagiotis Xaplanteris, MD
- Recruiting
CHU de Charleroi
Charleroi
Adel Aminian, MD
- Recruiting
Hôpital de La Louvière - Site Jolimont
La Louvière
Claudiu Ungureanu, MD
Switzerland2 sites, 2 recruiting
- Recruiting
Basel University Hospital
Basel, Basel
Gregor Leibundgut, MD
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Maëlle Achard, RN, +41795533553, maelle.achard@hcuge.ch
Sophie Degrauwe, MD
Germany1 site, 1 recruiting
- Recruiting
Agaplesion Bethesda Krankenhaus Bergedorf
Hamburg
Karsten Schenke, MD, +40725541261, kardiologie.bkb@agaplesion.de
Greece1 site, 1 recruiting
- Recruiting
Patras University Hospital
Pátrai
Grigorios Tsigkas, MD
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Milan
Gabriele L Gasparini, MD
About this study
Official title: DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention (DISCO COMPLEX)
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.
In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.
No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.
Read the detailed description
The radial artery has become the standard vascular access site for most percutaneous coronary interventions (PCI) and is recommended by the most recent 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization, irrespective of clinical presentation. Patients undergoing PCI of complex coronary lesions, such as a chronic total occlusion (CTO), left main (LM) coronary artery disease, complex bifurcation lesions, or heavily calcified lesions, have however been either absent or under-represented in most trials supporting these guidelines.
The small size of the radial artery remains an important limitation for the use of large bore guiding catheters (>6 F), restricting thereby the treatment of highly complex lesions through the transradial approach. The 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) is a dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7F guiding catheter and an outer diameter smaller than current 7F sheaths.
A prospective, multicenter, observational study including 60 patients demonstrates that a transradial access (TRA) using the 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications.
In the Complex Large-Bore Radial Percutaneous Coronary Intervention (COLOR) randomized trial, 388 patients with planned PCI for complex coronary lesions were randomly allocated to a 7F TRA or 7F transfemoral access (TFA). Conventional TRA was associated with a significant reduction in clinically relevant access- site bleeding or vascular complications without affecting procedural success when compared to TFA among patients undergoing complex PCI with a 7F large bore access.
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI. The potential advantages of DRA when compared to TRA are contrasted by a slightly smaller size of the distal radial artery potentially impacting on device selection and procedural planning and by its less predictable course, due to the pronounced tortuosity and angulation of the vessel, leading to an overall higher number of puncture attempts, a longer time to achieve arterial access and a higher rate of access failure. These limitations may preclude the use of DRA for PCI of complex coronary lesions when a large bore guiding catheter is needed. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.
In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.
No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.
- Conditions
- Vascular Access Site Occlusion
- Being tested
- Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
- Keywords
- Radial artery access, Distal radial artery, Complex PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)Procedure or surgery
Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)
| Study group | Role | What they receive |
|---|---|---|
| Distal radial access | Experimental | Distal radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan) Receives: Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) |
| Conventional radial access | Active comparator | Conventional radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan) Receives: Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of forearm radial artery occlusion
US Doppler
Measured: At hospital discharge (assessed up to day 5)
Secondary outcomes (8)
Incidence of vascular access site-related bleeding
EASY criteria and BARC criteria
Measured: At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related complication
Clinical assessment
Measured: At hospital discharge (assessed up to day 5)
Incidence of radial artery spasm
Angiographic assessment
Measured: During intervention (up to day 1)
Incidence of distal radial artery occlusion
US Doppler
Measured: At hospital discharge (assessed up to day 5)
Total hemostasis time
Clinical assessment
Measured: At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related pain
Visual Analogue Scale (VAS, 0-10, lower scores represent less pain)
Measured: At hospital discharge (assessed up to day 5)
Incidence of hand dysfunction
Michigan Hand Outcomes Questionnaire (MHQ: 0-100, lower pain scores denote less pain, other high scores denote better hand performance) and QuickDASH Outcome Measure Questionnaire (0-100, lower scores indicate lower level of disability)
Measured: At hospital discharge (assessed up to day 5) and at 1 year
Rate of target lesion failure
Composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start31 Aug 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access Site OcclusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IGLESIAS Juan Fernando
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, IGLESIAS Juan Fernando, University Hospital, Geneva
- Investigators
- Juan F. Iglesias, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490238
- Sponsor's protocol ID
- 2022-0729
- Acronym
- DISCO COMPLEX
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request to the principal investigator after publication of the study primary and secondary endpoints.
Publications
Iglesias JF, Leibundgut G, Heg D, Gasparini GL, Tsigkas G, Ungureanu C, Colletti G, Degrauwe S, Xaplanteris P, Schenke K, Achim A, van Leeuwen MA, Muresan M, Saito S, Sgueglia GA, Aminian A. Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial. Am Heart J. 2026 Feb;292:107291. doi: 10.1016/j.ahj.2025.107291. Epub 2025 Oct 18.
PubMed 41115584
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention (DISCO COMPLEX)
- ClinicalTrials.gov ID
- NCT05490238
- Acronym / sponsor ID
- DISCO COMPLEX / 2022-0729
- Conditions
- Vascular Access Site Occlusion
- Keywords
- Radial artery access, Distal radial artery, Complex PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- IGLESIAS Juan FernandoUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Aug 2022 (actual)
- 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.
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.
In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.
No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.
Detailed description
The radial artery has become the standard vascular access site for most percutaneous coronary interventions (PCI) and is recommended by the most recent 2018 European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines on myocardial revascularization, irrespective of clinical presentation. Patients undergoing PCI of complex coronary lesions, such as a chronic total occlusion (CTO), left main (LM) coronary artery disease, complex bifurcation lesions, or heavily calcified lesions, have however been either absent or under-represented in most trials supporting these guidelines.
The small size of the radial artery remains an important limitation for the use of large bore guiding catheters (>6 F), restricting thereby the treatment of highly complex lesions through the transradial approach. The 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) is a dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7F guiding catheter and an outer diameter smaller than current 7F sheaths.
A prospective, multicenter, observational study including 60 patients demonstrates that a transradial access (TRA) using the 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications.
In the Complex Large-Bore Radial Percutaneous Coronary Intervention (COLOR) randomized trial, 388 patients with planned PCI for complex coronary lesions were randomly allocated to a 7F TRA or 7F transfemoral access (TFA). Conventional TRA was associated with a significant reduction in clinically relevant access- site bleeding or vascular complications without affecting procedural success when compared to TFA among patients undergoing complex PCI with a 7F large bore access.
The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI. The potential advantages of DRA when compared to TRA are contrasted by a slightly smaller size of the distal radial artery potentially impacting on device selection and procedural planning and by its less predictable course, due to the pronounced tortuosity and angulation of the vessel, leading to an overall higher number of puncture attempts, a longer time to achieve arterial access and a higher rate of access failure. These limitations may preclude the use of DRA for PCI of complex coronary lesions when a large bore guiding catheter is needed. There is however limited evidence on the feasibility and safety of 7F DRA for PCI.
In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates.
No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal radial access | Experimental | Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)Distal radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan) |
| Conventional radial access | Active comparator | Procedure: Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)Conventional radial access using 7Fr Glidesheath Slender sheath (Terumo Corp., Japan) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Patients presenting with CCS or ACS, including unstable angina or NSTEMI.
- Patients planned for PCI of complex coronary lesions, such as CTO, left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions in whom the operator anticipates that a 7F guiding catheter is indicated.
- Patients able to provide written informed consent.
Key exclusion criteria (6 listed)
- Patients with acute ST-segment elevation myocardial infarction.
- Patients with cardiogenic shock.
- Patients on chronic hemodialysis.
- Patients with contraindications to TRA, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides.
- Patients with medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation.
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 |
|---|---|---|
| Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan)Large-bore radial access for complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) | Procedure or surgery | Conventional radial access, Distal radial access |
Primary outcome
Incidence of forearm radial artery occlusion
Time frame: At hospital discharge (assessed up to day 5)
US Doppler
8 secondary outcomes
Incidence of vascular access site-related bleeding
Time frame: At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related complication
Time frame: At hospital discharge (assessed up to day 5)
Incidence of radial artery spasm
Time frame: During intervention (up to day 1)
Incidence of distal radial artery occlusion
Time frame: At hospital discharge (assessed up to day 5)
Total hemostasis time
Time frame: At hospital discharge (assessed up to day 5)
Incidence of vascular access site-related pain
Time frame: At hospital discharge (assessed up to day 5)
Incidence of hand dysfunction
Time frame: At hospital discharge (assessed up to day 5) and at 1 year
Rate of target lesion failure
Time frame: At 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 41115584Iglesias JF, Leibundgut G, Heg D, Gasparini GL, Tsigkas G, Ungureanu C, Colletti G, Degrauwe S, Xaplanteris P, Schenke K, Achim A, van Leeuwen MA, Muresan M, Saito S, Sgueglia GA, Aminian A. Distal versus conventional radial large-bore access for percutaneous coronary intervention of complex coronary lesions: Rationale and design of the DISCO COMPLEX randomized superiority trial. Am Heart J. 2026 Feb;292:107291. doi: 10.1016/j.ahj.2025.107291. Epub 2025 Oct 18.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request to the principal investigator after publication of the study primary and secondary endpoints.
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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.
Juan F. Iglesias, MD principal investigator
University Hospital, Geneva
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex PCI with Ultimaster family drug-eluting stent (Terumo Corp., Japan) in people with Vascular Access Site Occlusion, run by IGLESIAS Juan Fernando at 9 sites in 5 countries.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Switzerland, Germany, Greece, Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Menoni (+41795530516, veronique.menoni@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of forearm radial artery occlusion (time frame: At hospital discharge (assessed up to day 5)). 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 NCT05490238, which also lists 1 linked publication.
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 15 Oct 2026.