Outpatient Office Based Endovascular Procedures

• Conditions: Chronic Venous Insufficiency; Peripheral Arterial Disease; Dialysis Access Malfunction; Arterio-venous Fistula; Vertebral Artery Insufficiency; Thoracic Outlet Syndrome; Varicose Veins

• Registration Number: NCT04054440
• Lead Sponsor: Methodist Health System

Brief Summary

The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite. Additionally, other studies could compare clinical outcomes between procedures performed in an office based angiosuite and other settings.

Detailed Description

Endovascular surgery combined with the demands of patients and physicians for less invasive procedures, have make this type of surgery one of the most innovative fields in medicine. However the endovascular experience in an office-based angiosuite is different from that in a hospital suite, and has been viewed in the past by some physicians as unsafe because it lacks the safety net of immediate hospital resources. In 2005, medicine allowed endovascular procedures to be performed in the office setting. The results of this study will serve as a starting point for future trials concentrating on the effectiveness and clinical outcomes of the procedures performed in an office based angiosuite.

Study Timeline

• Study Start: 2014-06-20
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥ 18 years.
• Diagnosis of peripheral arterial disease (PAD), chronic venous insufficiency, dialysis access and malfunctioning arteriovenous fistulas, varicose veins, vertebrobasilar insufficiency, and thoracic outlet syndrome.
• Procedures performed as an outpatient in an office based angiosuite.

Exclusion Criteria

• Age ≤ 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discharge location	April 2006 to December 2018	classified as home, hospital floor, ICU and emergency room.
postoperative complications	April 2006 to December 2018	events that disrupted the normal recovery process of the patient within the 24 hours following the procedure

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States