Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604340
Status:
TERMINATED
Last Update Posted:
2021-10-28
First Post:
2020-10-01
Brief Title:
Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents A Randomized-controlled Study
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient enrolment-radial access for neuroangiography is now accepted as clinical standard
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare radial vs femoral access for angiography in adolescents Neuroangiography and neurointerventions are predominantly performed via femoral access which has several limitations and complications - pain and discomfort arterial occlusion retroperitoneal hemorrhage activity limitations and increased admissions Transradial angiography has shown promise to circumvent these problems but this has not been studied in children whose unique anatomical and physiological aspects require that this be evaluated rigorously
Detailed Description:
Specific Aims
Angiography in interventional radiology is still most commonly performed through femoral arterial access wherein patients are committed to invasive procedures through access at their groin which entails anxiety embarrassment pain and discomfort the inability to resume normal activities for a week serious complications like retroperitoneal hemorrhage and increased hospital admissions Angiography through access at the wrist transradial angiography has been shown with some recent data to circumvent these complications and in general provide a more satisfactory and safe patient experience Although transradial angiography has been rapidly accepted by some operators especially in Cardiology the absence of evidence for technical details and safety has resulted in much debate in the literature and in recent conferences Specifically there is no literature reported in children The benefits of a method which would allow mobility immediately after the procedure in children are self-evident - this would potentially result in less rebleeds require little or no sedation allow sitting up and feeding and allow parents to interact with their child and feel more comfortable On the flip side the feasibility and potential complications in children are unknown and thus this technique cannot be integrated into clinical practice without interrogating this This should be ideally performed in a high volume pediatric center with expertise in not only pediatric neuroangiography but also for minimally invasive arterial access with interventional radiology to minimize complications Given the size consideration of arteries in children we believe a good start point for this study would be with adolescent children
The Investigators objective is to provide the highest level of evidence RCT data for feasibility safety and technique of transradial angiography in adolescents by comparing it against the current gold standard trans-femoral angiography This will provide data for subsequent practice guidelines
This study will be performed in a tertiary pediatric institution with collaboration between interventional radiologists neuroradiologists pediatricians neurosurgeons technologists statisticians research co-ordinators and imaging physicists A large number of clinical cases established pipelines for clinical workflow and research collaborations and imaging laboratories with personnel and students would enable us to successfully complete this project in a timely manner
Neuroangiography and neurointerventions are predominantly performed via femoral access which has several limitations and complications - pain and discomfort arterial occlusion retroperitoneal hemorrhage activity limitations and increased admissions Transradial angiography has shown promise to circumvent these problems but this has not been studied in children whose unique anatomical and physiological aspects require that this be evaluated rigorously
Primary aim
To evaluate procedural comfort and acceptance of transradial vs transfemoral neuroangiography in a cohort of randomized adolescent children This will be performed using patient self-reported pain and satisfaction scores
Secondary aim
1 To evaluate procedural safety for transradial vs transfemoral neuroangiography in a cohort of adolescent children This will be performed by comparing fluoroscopy time and dose procedural and long-term complication rates study completeness and admission times
Methods Children 8-18 years scheduled for supra-aortic angiography will be approached to participate Inclusion cut-offs radial artery ultrasound diameter 20mm and positive Allen test For 95 power primary aim the Investigator will require a sample size of 56 Neuroangiography will be performed as clinically indicated with collection of demographics procedural details screening time radiation dose completeness and complications and post-procedural details visual analog pain scale satisfaction score complications A Data Safety Monitoring board will audit the trial
Outcome Measures Self-reported scores will be compared between groups for procedural acceptance complications will be compared for procedural safety
Significance 1 This study will provide the highest level evidence regarding role and safety of transradial neuroangiography in children 2 Subsequent development of practice guideline recommendations for a standardized protocol for transradial angiography in children
Angiography in interventional radiology is still most commonly performed through femoral arterial access wherein patients are committed to invasive procedures through access at their groin which entails anxiety embarrassment pain and discomfort the inability to resume normal activities for a week serious complications like retroperitoneal hemorrhage and increased hospital admissions Angiography through access at the wrist transradial angiography has been shown with some recent data to circumvent these complications and in general provide a more satisfactory and safe patient experience Although transradial angiography has been rapidly accepted by some operators especially in Cardiology the absence of evidence for technical details and safety has resulted in much debate in the literature and in recent conferences Specifically there is no literature reported in children The benefits of a method which would allow mobility immediately after the procedure in children are self-evident - this would potentially result in less rebleeds require little or no sedation allow sitting up and feeding and allow parents to interact with their child and feel more comfortable On the flip side the feasibility and potential complications in children are unknown and thus this technique cannot be integrated into clinical practice without interrogating this This should be ideally performed in a high volume pediatric center with expertise in not only pediatric neuroangiography but also for minimally invasive arterial access with interventional radiology to minimize complications Given the size consideration of arteries in children we believe a good start point for this study would be with adolescent children
The Investigators objective is to provide the highest level of evidence RCT data for feasibility safety and technique of transradial angiography in adolescents by comparing it against the current gold standard trans-femoral angiography This will provide data for subsequent practice guidelines
This study will be performed in a tertiary pediatric institution with collaboration between interventional radiologists neuroradiologists pediatricians neurosurgeons technologists statisticians research co-ordinators and imaging physicists A large number of clinical cases established pipelines for clinical workflow and research collaborations and imaging laboratories with personnel and students would enable us to successfully complete this project in a timely manner
Neuroangiography and neurointerventions are predominantly performed via femoral access which has several limitations and complications - pain and discomfort arterial occlusion retroperitoneal hemorrhage activity limitations and increased admissions Transradial angiography has shown promise to circumvent these problems but this has not been studied in children whose unique anatomical and physiological aspects require that this be evaluated rigorously
Primary aim
To evaluate procedural comfort and acceptance of transradial vs transfemoral neuroangiography in a cohort of randomized adolescent children This will be performed using patient self-reported pain and satisfaction scores
Secondary aim
1 To evaluate procedural safety for transradial vs transfemoral neuroangiography in a cohort of adolescent children This will be performed by comparing fluoroscopy time and dose procedural and long-term complication rates study completeness and admission times
Methods Children 8-18 years scheduled for supra-aortic angiography will be approached to participate Inclusion cut-offs radial artery ultrasound diameter 20mm and positive Allen test For 95 power primary aim the Investigator will require a sample size of 56 Neuroangiography will be performed as clinically indicated with collection of demographics procedural details screening time radiation dose completeness and complications and post-procedural details visual analog pain scale satisfaction score complications A Data Safety Monitoring board will audit the trial
Outcome Measures Self-reported scores will be compared between groups for procedural acceptance complications will be compared for procedural safety
Significance 1 This study will provide the highest level evidence regarding role and safety of transradial neuroangiography in children 2 Subsequent development of practice guideline recommendations for a standardized protocol for transradial angiography in children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None