Superior Vena Cava SyndromeHemodialysisNCT04637334
Superior Vena Cava Reconstruction in Patients on Hemodialysis
An observational study of Superior Vena Cava Syndrome, run by Methodist Health System at 1 site in United States.
Trial summary
The treatment objective for patients with SVC syndrome secondary to both malignant and benign etiologies is to reduce the elevated central venous pressures.1 However, the strategies are contingent upon the underlying disease process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Vena Cava Syndrome
- What is being tested?
- Superior vena cava reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2014to 6 May 2022
- 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: Patients who underwent SVC bypass procedures from January 2010 to June 2013 at Methodist Dallas Medical Center will be screened for participation in the study.
Who may be able to join
- Age ≥ 18 years
- Presence of SVC syndrome or SVC occlusion
- Presence of ESRD on hemodialysis
- Presence of upper extremity or neck access, either catheter or surgical fistula
- Patients who have received endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion
Who cannot join
- Patients who have not undergone endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
The treatment objective for patients with SVC syndrome secondary to both malignant and benign etiologies is to reduce the elevated central venous pressures.1 However, the strategies are contingent upon the underlying disease process. Thus the management of SVC syndrome ranges from medical or supportive care to surgical bypass,3 and it is important for physicians to understand the varied treatment modalities of this potentially life-threatening disease.17 Fortunately, the overwhelming majority of patients with SVC syndrome secondary to benign causes develop a physiologic compensation for the obstruction that can be treated with anticoagulation and endovascular modalities. Intervention for symptomatic relief may not be required.1 An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because the long-term durability of this treatment method remains to be assessed.
Read the detailed description
This case study will retrospectively review all SVC syndrome and/or occlusion procedures since January 2009. All patients were given adequate informed consent about the procedure and its benefits and complications.
Definitions of clinical outcomes will adhere to the Subcommittee on Reporting Standards in Venous disease.27 Risk factors and outcomes of these procedures will be retrospectively analyzed. Data collected included preoperative patient demographics, clinical status, noninvasive and invasive imaging, operative procedural details, post-operative complications, post-procedural imaging surveillance, adjunctive/re-intervention procedures, clinical outcome during follow-up, and mortality. Primary endpoints will be clinical outcome and patency. Secondary endpoints will be re-intervention rate and death within 30 days.
- Conditions
- Superior Vena Cava Syndrome
- Being tested
- Superior vena cava reconstruction
- Medical subject headings
- Superior Vena Cava Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior vena cava reconstructionProcedure or surgery
Endovascular therapy with percutaneous transluminal angioplasty (PTA) and, in recent years, with stenting of the SVC, has been performed with increasing frequency. An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because long-term durability of this treatment method remains to be assessed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome and patency
To report findings in patients with ESRD on hemodialysis who underwent SVC reconstruction
Measured: Upto 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start13 Sep 2014
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Vena Cava SyndromeStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Feldtman, M.D., Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637334
- Sponsor's protocol ID
- 2013.00.642.A
- Acronym
- Hemodialysis
- Status last verified
- Oct 2022
- First submitted
- 12 Aug 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Vena Cava Reconstruction in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT04637334
- Acronym / sponsor ID
- Hemodialysis / 2013.00.642.A
- Conditions
- Superior Vena Cava Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 13 Sep 2014 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 19 Nov 2020 (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 treatment objective for patients with SVC syndrome secondary to both malignant and benign etiologies is to reduce the elevated central venous pressures.1 However, the strategies are contingent upon the underlying disease process. Thus the management of SVC syndrome ranges from medical or supportive care to surgical bypass,3 and it is important for physicians to understand the varied treatment modalities of this potentially life-threatening disease.17 Fortunately, the overwhelming majority of patients with SVC syndrome secondary to benign causes develop a physiologic compensation for the obstruction that can be treated with anticoagulation and endovascular modalities. Intervention for symptomatic relief may not be required.1 An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because the long-term durability of this treatment method remains to be assessed.
Detailed description
This case study will retrospectively review all SVC syndrome and/or occlusion procedures since January 2009. All patients were given adequate informed consent about the procedure and its benefits and complications.
Definitions of clinical outcomes will adhere to the Subcommittee on Reporting Standards in Venous disease.27 Risk factors and outcomes of these procedures will be retrospectively analyzed. Data collected included preoperative patient demographics, clinical status, noninvasive and invasive imaging, operative procedural details, post-operative complications, post-procedural imaging surveillance, adjunctive/re-intervention procedures, clinical outcome during follow-up, and mortality. Primary endpoints will be clinical outcome and patency. Secondary endpoints will be re-intervention rate and death within 30 days.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent SVC bypass procedures from January 2010 to June 2013 at Methodist Dallas Medical Center will be screened for participation in the study.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Presence of SVC syndrome or SVC occlusion
- Presence of ESRD on hemodialysis
- Presence of upper extremity or neck access, either catheter or surgical fistula
- Patients who have received endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion
Key exclusion criteria (1 listed)
- Patients who have not undergone endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superior vena cava reconstructionEndovascular therapy with percutaneous transluminal angioplasty (PTA) and, in recent years, with stenting of the SVC, has been performed with increasing frequency. An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because long-term durability of this treatment method remains to be assessed. | Procedure or surgery | – |
Primary outcome
Clinical outcome and patency
Time frame: Upto 30 days
To report findings in patients with ESRD on hemodialysis who underwent SVC reconstruction
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 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
Robert Feldtman, M.D. principal investigator
The Methodist Hospital Research Institute
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 Superior Vena Cava Syndrome, 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 5 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 23 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?
Clinical outcome and patency (time frame: Upto 30 days). 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 23 Mar 2026.