Femoral Artery Hemostasis Without Manual Compression (FAST)

Central South University

Status: Completed

Conditions: Femoral Arterial Hemostasis

Treatments: Procedure: Novel method without manual compression; Procedure: Standard method with manual compression.

Study type: Interventional

Funder types: Other

Identifiers

NCT04689555

FAST2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Novel method without manual compression

Experimental group

Treatment:

Procedure: Novel method without manual compression

Standard method with manual compression

Active Comparator group

Treatment:

Procedure: Standard method with manual compression.