Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05490238 |
| Other study ID # |
2022-0729 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 31, 2023 |
| Est. completion date |
May 1, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
University Hospital, Geneva |
| Contact |
Maëlle Achard, RN |
| Phone |
+41795533553 |
| Email |
maelle.achard[@]hcuge.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
