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Completed

NCT Number: NCT04689555

Femoral Artery Hemostasis Without Manual Compression

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel method without manual compression

Procedure

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.

Standard method with manual compression.

Procedure

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.

Primary outcomes

  1. Composite of arterial access related complications

    Time frame: 1 month

    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

Secondary outcomes

  1. Time to hemostasis

    Time frame: 1 month

    From sheath removal to complete hemostasis

  2. Repeat manual compression

    Time frame: 1 month

    Need for repeated manual compression after end of closure procedure

  3. Total procedure time

    Time frame: 1 month

    From sheath removal to the end of the whole procedure

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Acronym: FAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2020
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.