Femoral Artery Hemostasis Without Manual Compression (FAST)

Safety and Efficacy of Femoral Artery Hemostasis Without Manual Compression After Femoral Artery Puncture (FAST): a Prospective, Randomized, Open-label, Controlled, Multicenter Trial

FAST trial is a prospective, randomized, controlled, multicenter study in participants needing hemostasis after femoral arterial puncture. All eligible participants will be randomly assigned to either manual compression or novel method without manual compression after femoral arterial puncture. This study is aimed to investigate if novel method without manual compression is noninferior to manual compression regarding access site complications.

Study Overview

• Status: Completed
• Conditions: Femoral Arterial Hemostasis
• Intervention / Treatment: Procedure: Novel method without manual compression; Procedure: Standard method with manual compression.

Detailed Description

The common femoral artery is the most frequently used access site in cardiovascular interventional therapy. Closure of the arteriotomy site is usually achieved by manual compression after femoral arterial puncture. There are many disadvantages of this standard method for hemostasis which is still related to high rate of access-site complications such as pseudoaneurysm, major bleeding, ipsilateral groin hematomas and so on. Several vascular closure devices are emerging as novel means for improving patient comfort and accelerating ambulation after invasive cardiovascular procedures performed via femoral arterial access, however, the cost performance and other aspects limit its wide application especially in developing countries.

Actually the investigators found a novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

FAST trial is aimed to investigate if the safety and efficacy of this novel method without manual compression is noninferior to the standard manual compression.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing femoral access cardiovascular interventional therapy
• Patient must be competent for providing informed written consent

Exclusion Criteria:

• Peripheral arterial occlusive disease
• Prior peripheral artery surgery
• Critical limb ischemic
• Femoral arterial intubation failure
• Uncontrolled hypertension >220/110 mmHg
• Coagulopathy (bleeding disorder)
• Local infection
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel method without manual compression	Procedure: Novel method without manual compression; Novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.
Active Comparator: Standard method with manual compression	Procedure: Standard method with manual compression.; Standard method for femoral artery hemostasis with manual compression.After sheath removal, manual compression was continued for at least 10 minutes or until hemostasis. After that four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of arterial access related complications	Composite of arterial access related complications, defined as the composite of: Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm; Pseudoaneurysm; AV-Fistula; Major bleeding; Critical limb ischemia; Local infection; Need for vascular surgical or interventional treatment	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to hemostasis	From sheath removal to complete hemostasis	1 month
Repeat manual compression	Need for repeated manual compression after end of closure procedure	1 month
Total procedure time	From sheath removal to the end of the whole procedure	1 month

Collaborators and Investigators

• Sponsor: Second Xiangya Hospital of Central South University
• Investigators: Study Chair: Shenghua Zhou, Ph.D, Second Xiangya Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FAST2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No