- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04054440
Outpatient Office Based Endovascular Procedures
March 20, 2026 updated by: Methodist Health System
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
26000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge location
Time Frame: April 2006 to December 2018
|
classified as home, hospital floor, ICU and emergency room.
|
April 2006 to December 2018
|
|
postoperative complications
Time Frame: April 2006 to December 2018
|
events that disrupted the normal recovery process of the patient within the 24 hours following the procedure
|
April 2006 to December 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sam S Ahn, MD, DFW Vascuclar
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2014
Primary Completion (Actual)
May 17, 2024
Study Completion (Actual)
May 17, 2024
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
August 12, 2019
First Posted (Actual)
August 13, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Brain Ischemia
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Atherosclerosis
- Arteriosclerosis
- Arterial Occlusive Diseases
- Peripheral Vascular Diseases
- Vascular Malformations
- Nerve Compression Syndromes
- Fistula
- Arteriovenous Malformations
- Vascular Fistula
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Peripheral Arterial Disease
- Varicose Veins
- Arteriovenous Fistula
- Thoracic Outlet Syndrome
- Vertebrobasilar Insufficiency
Other Study ID Numbers
- 020.VSX.2013.D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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