Ignite Creation Date:
2024-05-06 @ 5:58 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05490238
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2022-08-01
Brief Title:
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Sponsor:
IGLESIAS Juan Fernando
Organization:
University Hospital Geneva
Study Overview
Official Title:
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention DISCO COMPLEX
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCO COMPLEX
Brief 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 The feasibility of a distal radial access DRA for coronary angiography andor 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 andor 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 903 of patients and procedural success was achieved in 781 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 676 of patients with only one case 43 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
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 903 of patients and procedural success was achieved in 781 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 676 of patients with only one case 43 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 CardiologyEuropean 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 andor 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 andor 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 903 of patients and procedural success was achieved in 781 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 676 of patients with only one case 43 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
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 andor 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 andor 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 903 of patients and procedural success was achieved in 781 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 676 of patients with only one case 43 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 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