Exploratory research to shorten bed rest time after transfemoral artery angiography using a groin compression device (Rebelt) - Rebelt study

Okada Takuya0 sites200 target enrollmentMarch 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

March 20, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Okada Takuya

•1\. Patients who perform catheter therapy or angiography via trans\-femoral artery approach and fulfill the following;
•1\) A 4 or 5Fr. sheath is used.
•2\) Temporary hemostasis is achieved without abnormality by manual compression at the time of sheath removal.
•3\) Compression is started using a rebelt after temporary hemostasis.
•2\. The patient is at least 18 years of age at the time consent is obtained.
•3\. Written consent for participation in this clinical research has been obtained from the patient.

•1\. Patients taking two or more antiplatelet or anticoagulant drugs and unable to discontinue medications or reduce dose to aspirin only prior to the procedure.
•2\. Patients with high bleeding risk (platelet count \< 50,000, PT\-INR \>\= 1\.5\).
•3\. Intraoperative use of heparin and ACT at the time of sheath removal is \>180 seconds or not measured.
•4\. There are pain, a surgical wound, hernia, or other abnormality at the planned puncture site.
•5\. Inability to maintain supine rest after procedure.
•6\. Difficulty in communicating.
•7\. Other patients deemed inappropriate as research subjects by the investigators.