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Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI

NCT05790603 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-07-11

No results posted yet for this study

Summary

The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after coronary angiography (CAG) or percutaneous coronary intervention (PCI). The main questions aims to answer:

* What is the hemostatic effect of the patent hemostatic device with quantitative pressure after percutaneous coronary intervention?
* What are the precise hemostatic pressure and hemostatic time of the radial artery after CAG/PCI? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use patent hemostatic device with quantitative pressure (PHDQP-Band, China) while the CG will use the conventional radial artery hemostatic device (TR-Band, Japan) without pressure monitoring.

The primary outcomes is incidence of 24h radial artery occlusion (24h RAO). Secondary outcomes include time to hemostasis, bleeding, hematoma, 30d radial artery occlusion (30d RAO), pain, hand swelling, numberness, pseudoaneurysm, and radial artery stenosis.

Conditions

  • Percutaneous Coronary Intervention
  • Hemostasis

Interventions

DEVICE

Intervention group with PHD-Band

The initial compression pressure was systolic blood pressure plus 10mmHg. Pressure will be released by 20mmHg and 40mmHg 1 hour and 2 hours respectively after the surgery and then the band will be removed after 3 hours if no bleeding occurs. The compression will continue if bleeding occurs.

DEVICE

Control group with TR-Band

TR-Band will be inflated with 15 mL of air The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with appropriate volume of air until bleeding stops .

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Zhenhui Tao · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05790603 on ClinicalTrials.gov