Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization (HEMOSTAD-INC)

Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Intervention; Transradial Approach
• Intervention / Treatment: Device: Hemostatic device for distal radial approach.

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.

• Study Type: Interventional
• Enrollment (Estimated): 482
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cardiología Ignacio Chavez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Coronary artery disease including chronic coronary syndrome or acute coronary syndrome.
• Cardiovascular disease that requires coronary angiography in its approach.

Exclusion Criteria:

• Cardiogenic shock.
• Lesions in venous or arterial hemoducts.
• Impossibility to provide informed consent.
• Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned.
• Severe chronic renal failure (GFR less than 30 ml/min/m2)
• Patients diagnosed with cancer.
• Patient with rheumatological and hematological pro-thrombotic disorders.
• Non-hydrophilic radial introducer.
• Failed cannulation of the radial artery with an introducer.
• Successful trans-radial access that is crossed over to the femoral approach.
• Patients with an interventional procedure using a radial approach in the previous 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Terumo Radial Band; 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.; 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.; Other Names: PreludeSYNC distal; Terumo Radial Band
Active Comparator: PreludeSYNC distal; 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.; 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.; Other Names: PreludeSYNC distal; Terumo Radial Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Evaluated by clinical signs and ultrasound doppler.	30 days after the procedure
Incidence of hematoma at the approach site.	Evaluated by clinical signs. Classified according to EASY scale.	24 hours after the procedure.
Bleeding at the access site.	Evaluated by clinical signs.	24 hours after the procedure.
Neurological sequelae.	Evaluated by clinical signs.	24 hours after the procedure.
Incidence of radial artery pseudoaneurysms.	Evaluated by clinical signs and ultrasound doppler.	24 hours after the procedure.

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Distal Radial Artery Access; PreludeSYNC distal; Terumo Radial Band
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: 21-1255

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No