Star-Close Early Ambulation Trial (STRUT)

Ernest Mazzaferri

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: Walking

Study type: Interventional

Funder types: Other

Identifiers

NCT00590798

STRUT

Details and patient eligibility

About

To confirm that patients who receive the Star-Close vascular closure system (VCS) can safely ambulate within 30 minutes of catheterization.

Full description

To confirm that patients who receive the Star-Close vascular closure system (VCS) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted to for an outpatient left heart catheterization
• Catheterization through the femoral artery
• Able to ambulate at least 20 feet
• Able to receive the Star-Close Vascular Closure System
• Be a candidate for hospital discharge following catheterization

Exclusion criteria

• Known peripheral arterial disease
• Blood pressure greater than 180/110
• Pregnant or lactating
• Anemic or low blood count
• Blood thinning medication within 5 days before catheterization
• Unable to walk 20 feet with out rest
• Complications during catheterization procedure

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

1

Experimental group

Description:

Patients are asked to walk within 30 minutes after implantation of the Star- Close vascular closure system.

Treatment:

Behavioral: Walking