Peripheral Arterial DiseaseRADIANCYNCT05399680
Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
A study testing S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter in people with Peripheral Arterial Disease, run by Cordis US Corp. at 12 sites in 6 countries.
Trial summary
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 29 Jun 2022to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:
- ALL patients must meet the following criteria prior to enrollment:
- Age ≥ 18 years
- For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
- Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
- Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound
Show all 25Show fewer
- Eligibility for standard surgical repair, if necessary
- A patient who requires a coronary intervention should have it performed at least seven (7) days prior to treatment of the target lesion
- The patient must provide documented informed consent and any other documented authorization, as required, prior to initiation of the study procedure
- Per Investigator assessment, the patient is willing and able to be followed up to 30 days post-procedure for evaluation and complete all required assessments per the study protocol.
- Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is applicable) would be assessed via baseline angiography performed at the time of index procedure:
- The Investigator has assessed that the patient is a suitable candidate (i.e, meets all inclusion criteria and none of the exclusion criteria), for treatment of a lesion in the iliac, superficial femoral and/or proximal popliteal arteries via transradial approach and is eligible for conversion from a transradial to transfemoral approach, if it becomes necessary.
- The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following a transradial approach
- Patients whose target lesion is in the iliac artery must meet these additional criteria prior to enrollment:
- 11a. A single de novo or restenotic lesion ≥ 50% stenosis in the common and/or external iliac artery
- 12a. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 100 mm, by visual assessment, within or across the common or external iliac arteries. The stenosis must be treatable with no more than two stents (while minimizing stent overlap)
- 13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment
- 14a. Angiographic evidence of a patent profunda or superficial femoral artery in the diseased (target) limb
- Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria prior to enrollment:
- 11b. A single de novo or restenotic lesion ≥ 50% stenosis in the SFA and/or PPA
- 12b. Stenotic lesion (one long or multiple serial/tandem lesions) less than or equal to 150 mm, by visual assessment, within or across the SFA and/or PPA. The stenosis must be treatable with no more than two stents (while minimizing stent overlap)
- 13b. RVD ranging from 4.0 to 7.0 mm by visual assessment
- 14b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella
- 15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (<50% stenosis) of at least one of three vessels to the ankle or foot
- 16b. Adequate aortoiliac or common femoral "inflow" (defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion (defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion
Who cannot join
- Patients will be excluded if ANY of the following exclusion criteria apply:
- The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery).
- Previously deployed stent at the site of the target lesion
- The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
- Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
- Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus
Show all 27Show fewer
- The patient is receiving any form of dialysis.
- The patient is receiving any form of immunosuppressant therapy.
- Planned amputation
- Established vasospastic disease
- Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index procedure
- The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
- Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
- Bleeding diathesis
- Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot be medically managed.
- Known allergy or intolerance to Nitinol (nickel titanium)
- Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines.
- Known or suspected active infection at the time of the index procedure.
- Patient is currently participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or is planning to participate in such a study prior to their completion of this study.
- Patient has had a major surgical or interventional procedure unrelated to this study within 30 days prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment.
- Exclusion criteria 20 through 25 would be assessed via baseline angiography performed at the time of index procedure:
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
- Noted perforation of the target vessel
- Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
- Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-determined inability to treat the target lesion with a single stent, or procedures pre-determined to require stent-in-stent placement to obtain patency
- Presence of thrombus prior to crossing the lesion
- Successful PTA treatment of a target lesion in the SFA/PPA (defined as < 50% stenosis after PTA treatment)
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Austria4 sites
Univ Klinikum LKG Graz
Graz
Klinikum Klagenfurt am Wörtherse
Klagenfurt
Hanusch Krankenhaus
Vienna
Univ.-Klinik für Innere Medizin II
Vienna
France4 sites
Hospital Ambroise Pare
Boulogne-Billancourt
Groupe Hôpital Paris St Joseph
Paris
Clinique Rhena
Strasbourg
Clinique Pasteur
Toulouse
About this study
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.
Read the detailed description
RADIANCY was an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ self-expanding stent in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via transradial artery access. The study enrolled 151 subjects, 22 of which were enrolled as "roll-in" subjects, at 12 investigational sites across Europe. These subjects were followed up to 30 days post-procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath, SABERX RADIANZ™ PTA Balloon Catheter
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S.M.A.R.T. RADIANZ™ Vascular Stent SystemDevice
The S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery.
BRITE TIP RADIANZ™ Guiding SheathDevice
BRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery.
SABERX RADIANZ™ PTA Balloon CatheterDevice
SABERX RADIANZ™ is a catheter with a distal inflatable balloon.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Treatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices Receives: Device: S.M.A.R.T. RADIANZ™ Vascular Stent System; Device: BRITE TIP RADIANZ™ Guiding Sheath; Device: SABERX RADIANZ™ PTA Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge.
Measured: From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first
Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
Technical success at the conclusion of the index procedure, defined as successful insertion of the S.M.A.R.T. RADIANZ™ Vascular Stent System into the peripheral vasculature through the radial artery, successful deployment of the study device (S.M.A.R.T.™ stent) at the intended location, and successful withdrawal of the delivery system without conversion from radial to femoral artery access.
Measured: From the time of insertion to the time of withdrawal of the SMART RADIANZ Vascular Stent System through the radial access artery, within the same day or 24 hours from the procedure start time
Secondary outcomes (6)
Device Deficiencies Through 30 Days Post-Procedure
For each of the three (3) devices, peri-procedural (within 30 days post-index procedure) rate of device deficiencies
Measured: From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
Adverse Events Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of adverse events
Measured: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of death, index limb amputation and target lesion revascularization
Measured: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Procedural Complications Through 30 Days Post-Procedure
Peri-procedural (within 30 days post-index procedure) rate of procedural complications
Measured: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath
Technical success associated with use of the BRITE TIP RADIANZ™ Guiding Sheath, defined as successful insertion of the device into the peripheral vasculature through the radial artery (allowing for introduction of interventional and/or diagnostic devices) and successful withdrawal of the device.
Measured: From the time of insertion through the time of withdrawal of the BRITE TIP RADIANZ™ Guiding Sheath through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure.
Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter
Procedural success associated with use of the SABERX RADIANZ™ PTA Balloon Catheter for pre-dilation and/or post-deployment stent dilatation (whenever applicable), defined as successful insertion of the device into the peripheral vasculature through the radial artery, successful inflation and deflation of the balloon, successful withdrawal of the device, and achievement of a final residual diameter stenosis of < 30% at the conclusion of the index procedure.
Measured: From the time of insertion to the time of withdrawal of the SABERX RADIANZ™ PTA Balloon Catheter through the radial access artery AND assessment of the final residual diameter stenosis, within the same day or 24 hours from the procedure start time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start29 Jun 2022
- Primary completion22 Sep 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qserve, NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399680
- Sponsor's protocol ID
- P21-7701
- Acronym
- RADIANCY
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2022
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
- ClinicalTrials.gov ID
- NCT05399680
- Acronym / sponsor ID
- RADIANCY / P21-7701
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- Qserve, NAMSA
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical investigation was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ Nitinol Stent, in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.
Detailed description
RADIANCY was an acute, multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study, whose primary objective was to evaluate acute safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System, when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter, to deploy the S.M.A.R.T.™ self-expanding stent in the treatment of patients with obstructive iliac or femoropopliteal arterial disease via transradial artery access. The study enrolled 151 subjects, 22 of which were enrolled as "roll-in" subjects, at 12 investigational sites across Europe. These subjects were followed up to 30 days post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: S.M.A.R.T. RADIANZ™ Vascular Stent System, Device: BRITE TIP RADIANZ™ Guiding Sheath, Device: SABERX RADIANZ™ PTA Balloon CatheterTreatment with SMART RADIANZ, BRITE TIP RADIANZ and SABERX RADIANZ devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age ≥ 18 years
- For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the index procedure
- Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
- Palpable radial artery with diameter ≥ 2.5 mm, as assessed by duplex ultrasound
- Eligibility for standard surgical repair, if necessary
Key exclusion criteria (27 listed)
- The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery).
- Previously deployed stent at the site of the target lesion
- The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
- Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
- Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus
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 |
|---|---|---|
| S.M.A.R.T. RADIANZ™ Vascular Stent SystemThe S.M.A.R.T. RADIANZ™ Vascular Stent System is designed to deliver the S.M.A.R.T.™ self-expanding stent (S.M.A.R.T.™ stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) sheathed delivery system introduced through the radial artery. | Device | Interventional |
| BRITE TIP RADIANZ™ Guiding SheathBRITE TIP RADIANZ™ is a catheter guiding sheath that facilitates percutaneous entry of an intravascular device into the peripheral vasculature through the radial artery. | Device | Interventional |
| SABERX RADIANZ™ PTA Balloon CatheterSABERX RADIANZ™ is a catheter with a distal inflatable balloon. | Device | Interventional |
Primary outcome
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome)
Time frame: From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first
Occurrence rate of CEC-adjudicated, major radial access site complications attributed to study device or procedure through time of hospital discharge.
Technical Success of Using the S.M.A.R.T. RADIANZ™ Vascular Stent System (Primary Efficacy Outcome)
Time frame: From the time of insertion to the time of withdrawal of the SMART RADIANZ Vascular Stent System through the radial access artery, within the same day or 24 hours from the procedure start time
Technical success at the conclusion of the index procedure, defined as successful insertion of the S.M.A.R.T. RADIANZ™ Vascular Stent System into the peripheral vasculature through the radial artery, successful deployment of the study device (S.M.A.R.T.™ stent) at the intended location, and successful withdrawal of the delivery system without conversion from radial to femoral artery access.
6 secondary outcomes
Device Deficiencies Through 30 Days Post-Procedure
Time frame: From the time of first use/handling of the device to 30 days from date of index procedure or study exit, whichever comes first
Adverse Events Through 30 Days Post-Procedure
Time frame: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Death, Index Limb Amputation and TLR Through 30 Days Post-Procedure
Time frame: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Procedural Complications Through 30 Days Post-Procedure
Time frame: From the time of introduction of the sheath through the radial access artery to 30 days from date of index procedure or study exit, whichever comes first
Technical Success of Using the BRITE TIP RADIANZ™ Guiding Sheath
Time frame: From the time of insertion through the time of withdrawal of the BRITE TIP RADIANZ™ Guiding Sheath through the radial access artery, assessed within the same day or 24 hours from the start time of the index procedure.
Procedural Success of Using the SABERX RADIANZ™ PTA Balloon Catheter
Time frame: From the time of insertion to the time of withdrawal of the SABERX RADIANZ™ PTA Balloon Catheter through the radial access artery AND assessment of the final residual diameter stenosis, within the same day or 24 hours from the procedure start time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S.M.A.R.T. RADIANZ™ Vascular Stent System, BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter in people with Peripheral Arterial Disease, run by Cordis US Corp. at 12 sites in 6 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 25 inclusion and 27 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: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria, France, Belgium, Italy, Spain and 1 more country. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome) (time frame: From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.