Efficacy and Safety of Hemostatic Methods in Distal Radia... | NCT05966376

NCT05966376

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Detailed Description

INTRODUCTION AND BACKGROUND

Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that this approach method mainly reduces the occlusion rate of the proximal radial artery, among other advantages; however, we still do not have scientific evidence on the various hemostasis methods for this approach. Practice varies between centers and countries and hemostasis methods vary from an elastic compression bandage to the use of devices manufactured specifically for this approach such as the PreludeSYNC DISTAL or modification of devices manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we intend to analyze the efficacy and safety of two hemostasis methods in patients who require an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no clinical trial that compares these methods face to-face in relation to their efficacy and safety. Retrospective studies indicate that both methods are effective in reducing radial artery occlusion and are safe in reducing the bleeding/hematoma rate.

THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR band) in patients undergoing percutaneous coronary intervention.

STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and comparative.

SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will undergo distal radial percutaneous coronary intervention/angiography.

METHODOLOGY After signing the informed consent, patients will be randomized by balanced block methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the Modified Radial Band device.

PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modified Terumo Radial Band	Experimental	A standard hemostatic device used for proximal radial approach. The hard plastic component is removed to achieve better attachment in the distal radial approach. Clean and dry the puncture site. The introducer is withdrawn 2 cm. Place the device on the patient's hand depending on the approach side. Terumo logo is positioned toward the little finger side. The green mark is positioned 1 cm proximal to the puncture site. The bands are adjusted and fixed around the wrist. The Terumo syringe is filled with 15 ml of air. The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously. Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified. Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon is inflated to achieve adequate hemostasis.	Device: Hemostatic device for distal radial approach.
PreludeSYNC distal	Active Comparator	A specific hemostatic device, designed for distal radial approach. Clean and dry the puncture site. Selection and preparation of the PreludeSYNC distal device according to the approach side. The introducer is withdrawn 2cm. The hemostasis device is placed on the patient's hand. Bands position: 1) little finger side; 2) thumb side; 3) between the thumb and the index finger. The circular mark of the balloon is positioned 1cm proximal to the puncture site. Bands are adjusted and fixed. The syringe is filled with 10 ml of air. The balloon of the device is slowly inflated while the introducer is slowly withdrawn simultaneously. Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified. Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon should be inflated to achieve adequate hemostasis.	Device: Hemostatic device for distal radial approach.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hemostatic device for distal radial approach.	Device	Hemostasis after distal radial approach is done with one of two devices, one of them is designed specifically for the distal radial approach; the other is not but a modified technique with the last one could be helpful.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.	At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.	24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.

Secondary Outcomes

Measure	Description	Time Frame
Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.	Evaluated by clinical signs and doppler.	24 hours after the procedure.
Radial arterial patency at 30 days in patients with obstruction at 24 hours.

Eligibility Module