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NCT04054440 Clinical Trial

Outpatient Office Based Endovascular Procedures

Peripheral Arterial Disease Clinical Trial

Official title:
Outpatient Office Based Endovascular Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04054440
Other study ID # 020.VSX.2013.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 20, 2014
Est. completion date May 17, 2024

Study information
Verified date March 2024
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date May 17, 2024
Est. primary completion date May 17, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Discharge location classified as home, hospital floor, ICU and emergency room. April 2006 to December 2018
Primary postoperative complications events that disrupted the normal recovery process of the patient within the 24 hours following the procedure April 2006 to December 2018
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