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

NCT05790603 | Recruiting DMC

• 1 other identifier: 2023SF05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Percutaneous coronary intervention; Radial artery hemostasis; Quantitative pressure; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Incidence early radial artery occlusion

  RAO occurs within 24 hours after CAG/PCI

  Within 24 hours after CAG/PCI

Secondary Outcomes (8)

• Compression time

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

• Incidence of access site bleeding

  Within 24 hours after CAG/PCI

• Incidence of hematoma

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

• Incidence of 30d radial artery occlusion

  Within 30 days after CAG/PCI

• The degree of pain

  baseline; 24 hours after PCI

Study Arms (2)

Intervention group

EXPERIMENTAL

PHD-band Group

Device: Intervention group with PHD-Band

Control group

ACTIVE COMPARATOR

TR-band Group

Device: Control group with TR-Band

Interventions

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.

Also known as: Brand name: WEGO Medical Products Group CO. LTD, China

Intervention group

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 .

Also known as: Brand name: Terumo Medical Corporation, Japan

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent.

You may not qualify if:

• Radial artery malformation； Chronic kidney disease with eGFR\<30ml/min.1.73m2; Cirrhosis of the liver; Coagulation disfunction; Patients treated with IIb / IIIa receptor antagonist.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (2)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Related Publications (4)

• Petroglou D, Didagelos M, Chalikias G, Tziakas D, Tsigkas G, Hahalis G, Koutouzis M, Ntatsios A, Tsiafoutis I, Hamilos M, Kouparanis A, Konstantinidis N, Sofidis G, Pancholy SB, Karvounis H, Bertrand OF, Ziakas A. Manual Versus Mechanical Compression of the Radial Artery After Transradial Coronary Angiography: The MEMORY Multicenter Randomized Trial. JACC Cardiovasc Interv. 2018 Jun 11;11(11):1050-1058. doi: 10.1016/j.jcin.2018.03.042.

  PMID: 29880098 BACKGROUND

• Deitrich-MacLean G, Walden T. Distinguishing teaching interactions of physically abusive from nonabusive parent-child dyads. Child Abuse Negl. 1988;12(4):469-79. doi: 10.1016/0145-2134(88)90064-6.

  PMID: 3233513 BACKGROUND

• Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.

  PMID: 35694680 BACKGROUND

• Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN, Salido DZ, Vega Servin NS, Soto-Lopez ME, Gaspar J. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022 May 23;15(10):1022-1029. doi: 10.1016/j.jcin.2022.03.011.

  PMID: 35589232 RESULT

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zhenhui Tao

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Zhenhui Tao

CONTACT

+8613811839842; terry1018china@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One of the primary outcome of radial artery occlusion will be assessed by masking the assessor. The data analyzers will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 30, 2023
• Study Start: May 21, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)