Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization

NCT05966376 | Unknown DMC

• 1 other identifier: 21-1255
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Intervention; Transradial Approach

Keywords

Distal Radial Artery Access; PreludeSYNC distal; Terumo Radial Band

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.

  24 hours after the procedure.

• Radial arterial patency at 30 days in patients with obstruction at 24 hours.

  30 days after the procedure

• Incidence of hematoma at the approach site.

  24 hours after the procedure.

• Bleeding at the access site.

  24 hours after the procedure.

• Neurological sequelae.

  24 hours after the procedure.

Study Arms (2)

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 * The introducer is withdrawn 2 cm.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 * The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously. * Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.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

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.

Also known as: PreludeSYNC distal, Terumo Radial Band

Modified Terumo Radial Band; PreludeSYNC distal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chávez

Mexico City, 14080, Mexico

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: July 28, 2023
• Study Start: February 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ME (1)