NCT04054440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2014

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2024

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2024

Enrollment Period

9.9 years

First QC Date

August 12, 2019

Last Update Submit

March 20, 2026

Conditions

Keywords

office based angiosuite

Outcome Measures

Primary Outcomes (2)

  • Discharge location

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

    April 2006 to December 2018

  • postoperative complications

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

    April 2006 to December 2018

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Age ≤ 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseArteriovenous FistulaThoracic Outlet SyndromeVertebrobasilar InsufficiencyVaricose Veins

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesVascular FistulaCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Sam S Ahn, MD

    DFW Vascuclar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 13, 2019

Study Start

June 20, 2014

Primary Completion

May 17, 2024

Study Completion

May 17, 2024

Last Updated

March 24, 2026

Record last verified: 2024-03

Locations