Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04080700 |
| Other study ID # |
KODRA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2019 |
| Est. completion date |
January 23, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Wonju Severance Christian Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The left distal radial approach (DRA) has been introduced as a feasible and safe alternative
route of the radial artery. However, there is still lack of evidence for DRA regarding the
feasibility, safety, effective time for hemostasis and hemostasis method. This prospective
multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.
Description:
Based on the results that radial approach (RA) reduced mortality and bleeding complications
compared with femoral approach (FA), RA has become the standard of care for coronary
angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better
comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018
ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding
procedural considerations.
Operators usually prefer right RA because most of the operators are right-handed and right
hand of the patient is closer to the operator. In contrast, longer distance to the left
radial artery cause neck or back sprain of the operators, especially when the height of the
operator is short, or the patient is obese. Nevertheless, left RA might be easier to
manipulate catheter because of less tortuosity compared to the right RA and similar approach
curvature with FA. Left RA also gives a chance to the right-handed patients to use their
right hand freely.
Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe
alternative route of the radial artery. The left hand in the prone position is placed either
on the left groin or beside the left hip according to operator preference. The operator
punctures the distal radial artery around the anatomical snuffbox. After the first report for
the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the
success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and
98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor
hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as
distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula.
Several studies for DRA also showed similar favorable results regarding procedural success
and bleeding complications.
Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig
prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in
case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be
a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can
have a potential benefit in patients requiring arteriovenous fistula and in patients who need
the radial artery as a conduit for coronary artery bypass graft because of the absence of
radial injury.
There is still lack of evidence for DRA regarding the feasibility, safety, effective time for
hemostasis and hemostasis method. Unknown complications related to DRA also should be
addressed. Therefore, this prospective multicenter registry aimed to investigate the safety
and efficacy of DRA for CAG and PCI.
