The objective of this study is to demonstrate the superiority of Distal Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Forearm radial artery occlusion (RAO) rate before discharge.
Following the procedure, the patient will be treated in accordance with
hospital standard of care and data will be collected until discharge.
Assessment for Radial Artery Occlusion (RAO):
The diagnosis of RAO (Radial Artery Occlusion) is made by an independent
investigator (not the operator) assessing the presence or absence of a 2D
Doppler Ultrasound flow signal at distal to the original entry site between 8
and 48 hours after the procedure.
If the patient is randomized to distal transradial access group, both forearm
and distal radial patency must be checked.
Local bleeding:
The diagnosis of puncture site bleeding is made before discharge and using the
EASY (visual assessment) and BARC criteria*s.
Activated Clotting Time (ACT):
ACT should be performed before removal of the sheath.
Pain Assessment by VAS (Visual Assessment Score):
The procedural pain intensity is measured by the Visual Assessment Scale (VAS),
a numeric rating scale. VAS is a 10 cm line with anchor statements on the left
(no pain = 0) and on the right (worst possible pain = 10). The patient is asked
to mark their current pain level on the line. The examiner scores the VAS by
measuring the distance in centimeters (0 to 10) from the *no pain* anchor
point.
The pain score need to be taken immediately after sheath removal on the bed.
It takes into account from the puncture and cannulation until sheath removal.
Secondary outcome
- Rate of successful sheath insertion.
- Rate of access site crossover (See definition given in point 6.7)
- Total procedural time.
- Sheath insertion time.
- Puncture site bleeding according to EASY criteria. (See definition in
Appendix B).
- Overall bleeding according to BARC criteria. (See definition in Appendix B).
- Vascular access-site complication. (See definition in Appendix B).
- Rate of radial artery spasm. (See definition in Appendix B).
- Rate of distal radial artery occlusion (dRAO).
- Patent hemostasis was achieved or not (CTRA) by reverse Barbeau test. (See
point 6.4 for more information).
- Time required to reach hemostasis.
- Pain associated with the procedure.
Background summary
On September 16th, 1977, Dr Andreas Gruentzig performed the first successful
angioplasty treatment in a patient with angina on exertion in Zurich,
Switzerland, which was the first case of percutaneous coronary intervention
(PCI). Since then, PCI had established a definite role in the treatment of
ischemic heart disease. In order to perform PCI, it is necessary to make an
access to the peripheral arteries by an arterial puncture or cut down, which
can be performed in several ways.
Percutaneous transfemoral approach is the first adopted access approach and has
been used widely. In 1992, Dr Ferdinand Kiemeneij performed the first
transradial percutaneous coronary balloon angioplasty and coronary stenting in
Amsterdam (1). In the last decades, the transradial approach has emerged as the
preferred vascular access for angiography and PCI, due to its advantages over
femoral approach including effective hemostasis due to the easy compressibility
of the radial artery, reduction of vascular complications and immediate
ambulation after the examination. These features of radial access have a
positive impact on the reduction of hospital stay and hospitalization costs.
The radial approach for PCI has been validated in numerous trials and
meta-analyses showing a reduction in bleeding complications. In patients
presenting with an acute coronary syndrome (ACS), radial access, compared to
femoral access reduces not only major bleeding complications but also all-cause
mortality. Based on the clinical evidence available, radial access has been
recommended in the 2018 ESC guidelines as standard approach, unless there are
overriding procedural considerations with evidence level Class I A (2).
Radial artery puncture and sheath insertion can induce acute injuries and
chronic thickening of the radial artery intima, which may subsequently result
in radial artery occlusion with or without thrombus formation (3,4). Although
radial artery occlusion (RAO) rarely induces hand ischemia under normal
bi-directional circulation between radial and ulnar arteries through the carpal
network (5), the repeated catheterization through the radial approach from the
same side becomes impossible (6). The incidence of a RAO after catheterization
is generally reported to be 1% to 10% and is influenced by many factors such as
the relative diameter of the sheath introducer versus the inner lumen of the
radial artery (7), the duration of hemostatic compression (8), maintenance of
radial artery patency during hemostasis (9), the use of hydrophilic-coated
introducer sheath (10), female gender, the presence of peripheral arterial
occlusive disease, younger age (11), and so on. Although transient compression
of the ulnar artery on the same side may facilitate the recanalization of the
occluded radial artery (12), its prevention is desirable.
Among the different factors that can contribute to the occurrence of RAO, the
size of the introducer sheath compared to the radial artery size is one of the
major determinants. The use of a 5Fr sheath can reduce the incidence of RAO
compared to the use of a 6Fr sheath (11). TERUMO corporation has developed a
6Fr sheath (Glidesheath slender: GSS), which is characterized by having an
inner lumen diameter like other contemporary 6Fr sheath as well as having an
outer diameter similar like a contemporary 5Fr sheath. The introduction of this
sheath into transradial access might help to reduce RAO compared to the use of
contemporary standard 6Fr sheath. Recent study by Dr Adel Aminian reported that
the Glidesheath Slender 6Fr showed a safe and feasible profile with a high rate
of procedural success and a low rate of RAO (13). Based on these experiences,
we finished the international RAP and BEAT clinical trial for 1,900+ case,
which revealed various important findings on RAO. The result was already
published (14).
Study objective
The objective of this study is to demonstrate the superiority of Distal
Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding
forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).
Study design
DISCO RADIAL is a prospective, global, open label, multicenter randomized
controlled trial with plan to include approximately 1300 patients on who
transradial coronary angiography and/or intervention is performed. The patients
will be randomized in 1:1 ratio to either Distal Transradial Artery Access
(DTRA) or the Conventional Transradial Access (CTRA) arm. In both arms 6Fr
Glidesheath Slender * (GSS) will be used as access sheath.
Study burden and risks
Risks/complications related to transradial catheterization
These include, but are not limited to the following:
• Bleeding
• Radial artery spasm
• Radial artery occlusion
• Pain
• hematoma of the wrist and/or forearm
• Transitory finger numbness
• Radial artery dissection
• AV fistula
• Pseudoaneurysm
Risk associated with Angiography, Cardiac Catheterization, Stenting and
Percutaneous Transcatheter Coronary Angioplasty
The amount of radiation you will be exposed to with angiography is small. Such
doses of radiation may be possibly harmful, but the risks are so small that
they are hard to measure.
During the angiography the doctor will use a liquid that will help to see the
blood vessels in the area to be treated. This liquid is called contrast medium
and it can cause problems in patients with kidney disease. Contrast medium can
raise or lower blood pressure, cause abnormal heart rhythms, trigger allergic
reactions or cause nausea and vomiting.
Coronary angioplasty, catheterization and stenting procedure have established
the definite role in the treatment of ischemia heart disease. There is
extensive clinical experience worldwide. The benefits of this procedure
outweighs the potentials risks, and it is expected that the procedural risks
will not be significantly different in this clinical trial.
Risks Associated with Blood Draws
Drawing blood may cause temporary discomfort from the needle stick, bruising or
infection.
Researchpark Haasrode 1520
Leuven 3001
BE
Researchpark Haasrode 1520
Leuven 3001
BE
Listed location countries
Age
Inclusion criteria
- Patient is at least 18 years of age.
- Patient has provided written informed consent.
- Patient is undergoing diagnostic coronary angiography and/or PCI.
- Patient is willing to comply with all protocol-required evaluations during
the hospitalization.
- Patient is suitable for both DTRA and CTRA using 6Fr GSS.
Exclusion criteria
- Patient has a medical condition that may cause non-compliance with the
protocol and/or confound the data interpretation.
- Patient is on chronic hemodialysis.
- Patient is presenting with ST-elevated myocardial infarction (STEMI).
- Patient has chronic total occlusion (CTO) lesions in coronary artery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04171570 |
| CCMO | NL74158.075.20 |