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CompletedNCT04054440Updated Mar 24, 2026

Outpatient Office Based Endovascular Procedures

An observational study in Chronic Venous Insufficiency, Peripheral Arterial Disease and Dialysis Access Malfunction, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
26,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • office based angiosuite
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 26,000 is above the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients who received endovascular procedures performed by board certified vascular surgeons in office-based angiosuites, located in California and Texas.

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

Exclusion Criteria:

  • Age ≤ 18 years
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
26,000 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Discharge location

    classified as home, hospital floor, ICU and emergency room.

    Time frame: April 2006 to December 2018

  2. postoperative complications

    events that disrupted the normal recovery process of the patient within the 24 hours following the procedure

    Time frame: April 2006 to December 2018

07

Study locations

1 site
  • Methodist Dallas Medical Center
    Dallas, Texas 75203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04054440
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Aug 13, 2019
Start date
Jun 20, 2014
Primary completion
May 17, 2024
Completion
May 17, 2024
Last update
Mar 24, 2026

Study contacts

Sam S Ahn, MD
principal investigator · DFW Vascuclar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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