Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty (ACCESS-II)

Christian Juhl Terkelsen

Status: Terminated

Conditions: Angiography; Radial; Angioplasty; Randomized; Ultrasound

Treatments: Diagnostic Test: Ultrasound guided sheath insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT03060460

ACCESS-II

Details and patient eligibility

About

The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.

Full description

A randomised study with an historical control group.

Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).

Only high-volume physicians who have passed a ultrasound course are allowed to include patients.

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible

Exclusion criteria

• Abnormal pulse oxymetry test
• If severe lower-extremity calcification is known to exclude femoral access

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Ultrasound arm - Randomized group

Experimental group

Description:

Ultrasound guided sheath insertion

Treatment:

Diagnostic Test: Ultrasound guided sheath insertion

Conventional arm - Randomized group

No Intervention group

Description:

Conventional arm during randomized phase

Historical control group

No Intervention group

Description:

Conventional arm, non-randomization phase