Cerebral AngiographyNCT06490848
Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods
A study testing Diagnostic cerebral angiography in people with Cerebral Angiography, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Angiography
- What is being tested?
- Diagnostic cerebral angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 1 Dec 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive adult inpatients and outpatients referred for diagnostic cerebral angiography
- the presence of the right radial pulse and at least one femoral pulse
Who cannot join
- age<18
- pregnant patients
- occlusion of aorta or proximal both iliac/ femoral artery
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad university of medical sciences
Mashhad, Razavi Khorasan Province
Humain Baharvahdat, MD, +98 915 1100 400, humainbv@gmail.com
Farid Qoorchi Moheb Seraj, MD, 98 936 939 24 44, presfqm@gmail.com
About this study
Official title: Comparing the Safety and Efficacy of Cerebral Angiography Using Trans-femoral Approach Versus Trans-radial Approach
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.
Read the detailed description
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.
- Conditions
- Cerebral Angiography
- Being tested
- Diagnostic cerebral angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic cerebral angiographyProcedure or surgery
In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.
| Study group | Role | What they receive |
|---|---|---|
| Transradial approach group | Active comparator | The diagnostic angiography was performed by radial approach. Receives: Procedure: Diagnostic cerebral angiography |
| Trasfemoral approach group | Active comparator | The diagnostic angiography was performed by femoral approach. Receives: Procedure: Diagnostic cerebral angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
technical success
Incidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover.
Measured: during procedure
access success
Incidence of puncture success to insert a sheat in the access point
Measured: during procedure
Secondary outcomes (3)
total procedure time
the duration (minutes) between the insertion of sheath and removal of sheath. fluoroscopy time, the need for performing 3D angiography, dose area product (DAP), total radiation dose, successful puncture (successful insertion of radial artery sheath and femoral artery sheath). Procedures that yielded angiograms with acceptable quality through the subclavian artery injection (with an inflated blood pressure cuff on the arm), in cases of failed vertebral artery cannulation, were also considered successful.
Measured: during procedure
total fluoroscopy time
the duration of fluoroscopy
Measured: during procedure
complication
incidence of any procedural-related complication procedure
Measured: during procedure or one week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Jan 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AngiographyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, all consecutive patients referred for diagnostic cerebral angiography at a large academic tertiary care medical center were randomly assigned to two groups: right radial access versus femoral access for diagnostic cerebral angiography.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humain Baharvahdat, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490848
- Sponsor's protocol ID
- 4001116
- Status last verified
- Jul 2024
- First submitted
- 17 Oct 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Efficacy of Cerebral Angiography Using Trans-femoral Approach Versus Trans-radial Approach
- ClinicalTrials.gov ID
- NCT06490848
- Acronym / sponsor ID
- 4001116
- Conditions
- Cerebral Angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.
Detailed description
Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, all consecutive patients referred for diagnostic cerebral angiography at a large academic tertiary care medical center were randomly assigned to two groups: right radial access versus femoral access for diagnostic cerebral angiography.
| Arm | Type | Receives |
|---|---|---|
| Transradial approach group | Active comparator | Procedure: Diagnostic cerebral angiographyThe diagnostic angiography was performed by radial approach. |
| Trasfemoral approach group | Active comparator | Procedure: Diagnostic cerebral angiographyThe diagnostic angiography was performed by femoral approach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consecutive adult inpatients and outpatients referred for diagnostic cerebral angiography
- the presence of the right radial pulse and at least one femoral pulse
Key exclusion criteria (3 listed)
- age<18
- pregnant patients
- occlusion of aorta or proximal both iliac/ femoral artery
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 |
|---|---|---|
| Diagnostic cerebral angiographyIn transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated. | Procedure or surgery | Transradial approach group, Trasfemoral approach group |
Primary outcome
technical success
Time frame: during procedure
Incidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover.
access success
Time frame: during procedure
Incidence of puncture success to insert a sheat in the access point
3 secondary outcomes
total procedure time
Time frame: during procedure
total fluoroscopy time
Time frame: during procedure
complication
Time frame: during procedure or one week after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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 study testing Diagnostic cerebral angiography in people with Cerebral Angiography, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 3 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 8 Jul 2024. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Humain Baharvahdat, MD (+ 98 915 1100 400, humainbv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
technical success (time frame: during procedure). 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 8 Jul 2024.