Chronic Venous InsufficiencyNCT04054440
Outpatient Office Based Endovascular Procedures
An observational study of Chronic Venous Insufficiency and Peripheral Arterial Disease, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, Peripheral Arterial Disease, Dialysis Access Malfunction
- How many people
- 26,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2014to 17 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients who received endovascular procedures performed by board certified vascular surgeons in office-based angiosuites, located in California and Texas.
Who may be able to join
- 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.
Who cannot join
- Age ≤ 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
- Conditions
- Chronic Venous Insufficiency, Peripheral Arterial Disease, Dialysis Access Malfunction, Arterio-venous Fistula, Thoracic Outlet Syndrome, Vertebral Artery Insufficiency
- Keywords
- office based angiosuite
- Medical subject headings
- Peripheral Arterial Disease, Arteriovenous Fistula, Thoracic Outlet Syndrome, Vertebrobasilar Insufficiency, Varicose Veins
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge location
classified as home, hospital floor, ICU and emergency room.
Measured: April 2006 to December 2018
postoperative complications
events that disrupted the normal recovery process of the patient within the 24 hours following the procedure
Measured: April 2006 to December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start20 Jun 2014
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam S Ahn, MD, Principal investigator, DFW Vascuclar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054440
- Sponsor's protocol ID
- 020.VSX.2013.D
- Status last verified
- Mar 2024
- First submitted
- 12 Aug 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Office Based Endovascular Procedures
- ClinicalTrials.gov ID
- NCT04054440
- Acronym / sponsor ID
- 020.VSX.2013.D
- Conditions
- Chronic Venous Insufficiency, Peripheral Arterial Disease, Dialysis Access Malfunction, Arterio-venous Fistula, Thoracic Outlet Syndrome, Vertebral Artery Insufficiency
- Keywords
- office based angiosuite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,000 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who received endovascular procedures performed by board certified vascular surgeons in office-based angiosuites, located in California and Texas.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Age ≤ 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discharge location
Time frame: April 2006 to December 2018
classified as home, hospital floor, ICU and emergency room.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam S Ahn, MD principal investigator
DFW Vascuclar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency and Peripheral Arterial Disease, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge location (time frame: April 2006 to December 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.