Iliac Vein Compression SyndromeNCT03309969
Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome
An observational study of Iliac Vein Compression Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Iliac Vein Compression Syndrome
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2017to 1 Mar 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with suspicious iliac vein compression syndrome
Who may be able to join
- Age: 18 to 90 years
- Willing to participate in and sign the informed consent
- Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)
- Patent common femoral vein and/or femoral vein of the study leg
- Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome
Who cannot join
- Not providing informed consent
- Venous compression caused by pelvic tumors or fibroid uterus
- Previous stent implantation or venovenous bypass surgery of the study leg
- Known metal allergy precluding the possibility of stent implantation
- Known iodine allergy or severe renal insufficient function which are unsuitable for venography
- Pregnant or planning to be pregnant recently
Show all 9Show fewer
- Acute deep vein thrombosis or tumor thrombus involving the study leg
- Know history of thrombophilia (e.g. protein C or S deficiency, anti-thrombin III deficiency, etc )
- Any concurrent disease, for example, heart failure, might make the patients unsuitable for surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Zhenyu Shi, doctor, +86 18616880807, maxshizhenyu@163.com
Zhenyu Shi, Professor
About this study
The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.
- Conditions
- Iliac Vein Compression Syndrome
- Medical subject headings
- May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observation group | Subjects with suspicious iliac vein compression syndrome were included in the observation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage diameter reduction
Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
Measured: 1 month
Percentage area reduction
Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography
Measured: 1 month
Secondary outcomes (3)
CEAP score
Improvement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score
Measured: 18 months
Primary patency
Primary patency can be defined as without additional revascularization of the target lesions, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is <50% during follow-up period.
Measured: 18 months
Secondary patency
Secondary patency can be defined as: with additional revascularization of the target lesions after the first surgery in our department, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is <50% during follow-up period.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start30 Oct 2017 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Vein Compression SyndromeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309969
- Sponsor's protocol ID
- B2017-115
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 16 Oct 2017
- 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 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome
- ClinicalTrials.gov ID
- NCT03309969
- Acronym / sponsor ID
- B2017-115
- Conditions
- Iliac Vein Compression Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Oct 2017 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 16 Oct 2017 (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 aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | –Subjects with suspicious iliac vein compression syndrome were included in the observation group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with suspicious iliac vein compression syndrome
Key inclusion criteria (5 listed)
- Age: 18 to 90 years
- Willing to participate in and sign the informed consent
- Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)
- Patent common femoral vein and/or femoral vein of the study leg
- Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome
Key exclusion criteria (9 listed)
- Not providing informed consent
- Venous compression caused by pelvic tumors or fibroid uterus
- Previous stent implantation or venovenous bypass surgery of the study leg
- Known metal allergy precluding the possibility of stent implantation
- Known iodine allergy or severe renal insufficient function which are unsuitable for venography
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
Percentage diameter reduction
Time frame: 1 month
Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography
Percentage area reduction
Time frame: 1 month
Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography
3 secondary outcomes
CEAP score
Time frame: 18 months
Primary patency
Time frame: 18 months
Secondary patency
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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Vascular Lab Resource (VLR) Biorepository
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Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
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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.
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 Iliac Vein Compression Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 16 Oct 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Shi, Doctor (+86 18616880807, maxshizhenyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage diameter reduction (time frame: 1 month). 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 16 Oct 2017.