Health TrialsbyHealthPanel

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

ConditionsPercutaneous Coronary InterventionHemostasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group with PHD-Band

    Device

    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.

  • Control group with TR-Band

    Device

    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 .

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence early radial artery occlusion

RAO occurs within 24 hours after CAG/PCI

Time frame
Within 24 hours after CAG/PCI

Secondary outcomes

1

Compression time

The interval from the time of sheath removal to the time of hemostasis removal

Time frame
through hemostasis completion，estimated to be an average of 3~6hours
2

Incidence of access site bleeding

Access site bleeding within 24 hours after CAG/PCI

Time frame
Within 24 hours after CAG/PCI
3

Incidence of hematoma

The incidence of subcutaneous hematoma in the distal skin of the compression site 24 h after the removal of the compression device

Time frame
through hemostasis completion，estimated to be an average of 4~6hours
4

Incidence of 30d radial artery occlusion

RAO occurs within 30 days after CAG/PCI

Time frame
Within 30 days after CAG/PCI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Xuanwu Hospital, Beijing

Collaborator

Source ClinicalTrials.gov
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