The objective of this study is to demonstrate the safety and efficacy of thenew 6Fr sheath (Glidesheath slender 6Fr; GSS 6Fr) compared with thecontemporary 5Fr sheath (standard of care 5Fr; SOC 5Fr) both from Terumo;Tokyo, Japan.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is composite of the freedom from radial artery occlusion
(RAO) and local bleeding from the puncture site at the time of discharge or
the next day, the earlier of the two.
Secondary outcome
Procedure success rate at the index procedure.
* Vascular access site complication
* Radial spasm during the index procedure.
* Total Procedure Time
* Total Amount of Contrast Dye
* Fluoroscope time
* Procedure failure due to the assigned sheath.
* Pain score
Background summary
Radial artery puncture and sheath insertion can induce acute injuries and
chronic
thickening of the radial artery intima, which may subsequently result in the
radial artery occlusion (RAO)
with or without thrombus formation. TERUMO corporation developed a new 6Fr
sheath (Glidesheath slender 6Fr: GSS
6Fr). It has the same inner lumen diameter as the contemporary 6Fr sheath but
the sheath outer
The Study Protocol of RAP and BEAT Clinical Trial
Confidential Document written by Shigeru SAITO, MD 9
Radifocus Introducer *H 6Fr
(Glidesheath) Glidesheath Slender 6Fr
diameter is similar to the contemporary 5Fr sheath. With the introduction of
this new sheath into
transradial coronary procedures, it is reasonably expected that PCI through TRI
can be
performed in the majority of real-world clinical situations without significant
limitations, while
reducing RAO by the use of smaller outer caliber sheath compared with the use
of contemporary
6Fr sheath.
A recent preliminary study by Amit Aminian reported that the Glidesheath
Slender 6Fr was safe
and feasible with a high rate of procedural success and a low rate of RAO
Study objective
The objective of this study is to demonstrate the safety and efficacy of the
new 6Fr sheath (Glidesheath slender 6Fr; GSS 6Fr) compared with the
contemporary 5Fr sheath (standard of care 5Fr; SOC 5Fr) both from Terumo;
Tokyo, Japan.
Study design
Investigators-initiated Randomized, prospective, controlled, open-labeled,
multicenter Clinical Trial (RCT):
Approximately 1,900 patients who undergo diagnostic coronary artery
angiography or subsequent percutaneous coronary intervention (PCI) via
transradial approach using any one of 4, 5, or 6Fr diagnostic catheters or
either 5 or 6Fr guiding catheters for subsequent PCI will be enrolled. Patients
are randomized 1:1 to receive GSS 6Fr sheath (950 patients) and SOC 5Fr
sheath (950 patients). The two patient groups will then be immediately
randomized again to 475 patients for Patent hemostasis with TR band
(Terumo co.) and 475 patients for any hemostasis procedure customarily
done as a standard practice in the hospital. The enrollment will be finished
when the number of patients who undergo coronary artery angiography
reaches 1,900 patients.
Intervention
receive GSS 6Fr sheath (950 patients) or SOC 5Fr
sheath (950 patients).
Study burden and risks
n/a
Kanagawa Prefecture 247-8533
Okamoto, Kamakura 1370-1
JP
Kanagawa Prefecture 247-8533
Okamoto, Kamakura 1370-1
JP
Listed location countries
Age
Inclusion criteria
5.4 General Inclusion Criteria
1. Patient must be at least 18 years of age.
2. Patient is able to verbally acknowledge an understanding of the associated risks, benefits
and treatment alternatives
3. Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
4. Patient must agree to undergo all protocol-required follow-up examinations.
5. Patient who can accept radial access.
Exclusion criteria
1. Patient has other medical illness (e.g., cancer or congestive heart failure) that may
cause non-compliance with the protocol, confound the data interpretation or is
associated with a limited life expectancy (i.e., less than one year).
2. Hemodialysis patient
3. STEMI
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 |
|---|---|
| CCMO | NL53530.029.15 |