Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05790603

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

Led by Peking University First Hospital · Updated on 2024-07-11

200

Participants Needed

2

Research Sites

27 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

X

Xuanwu Hospital, Beijing

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery
  • Positive Allen's test result
  • Willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Radial artery malformation
  • Chronic kidney disease with eGFR less than 30 ml/min/1.73 m2
  • Cirrhosis of the liver
  • Coagulation dysfunction
  • Patients treated with IIb/IIIa receptor antagonist

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Trial Site Locations

Total: 2 locations

1

Xuanwu Hospital

Beijing, Beijing Municipality, China, 100053

Not Yet Recruiting

2

Peking University First Hospital

Beijing, China

Actively Recruiting

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Research Team

Z

Zhenhui Tao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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