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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
| Duke Clinical Research Institute | OTHER |
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The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6Fr Glidesheath Slender sheath | Experimental | TRI will be performed using a new 6Fr sheath (Glidesheath slender: GSS). |
|
| 5Fr contemporary sheath | Active Comparator | TRI will be performed using a contemporary safety of 5Fr sheath. |
|
| Hemostasis with TR band | Experimental | Hemostasis is achieved by randomization of using TR band (TERUMO) Patent hemostasis. |
|
| Any hemostasis procedure | Active Comparator | Hemostasis is achieved by randomization of any hemostasis of each hospital's routine procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6Fr Glidesheath Slender sheath | Device | 6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath. |
| Measure | Description | Time Frame |
|---|---|---|
| Radial artery occlusion | Day 1 | |
| Local bleeding from puncture site | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success rate | Day 1 | |
| Vascular access site complication | Day 1 | |
| Radial spasm during the index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006487 | Hemostasis |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| 5Fr sheath | Device | 5Fr Hydrophilic coating sheath from Terumo. |
|
| Hemostasis with TR band | Procedure | Hemostasis is achieved using TR band (TERUMO) Patent hemostasis. |
|
| Any hemostasis procedure | Procedure | Hemostasis is achieved by any hemostasis of each hospital's routine procedure. |
|
| Day 1 |
| Total Procedure Time | Day 1 |
| Total Amount of Contrast Dye | Day 1 |
| Total Radiation Doses | Day 1 |
| Device failure for the assigned sheath introducer | Day 1 |
| Pain score | Day 1 |