Nonthrombotic Iliac Vein LesionsNCT06311669
Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions
A study testing iliac vein stenting and pelvic vein embolization in people with Nonthrombotic Iliac Vein Lesions and Pelvic Congestive Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Nonthrombotic Iliac Vein Lesions, Pelvic Congestive Syndrome
- What is being tested?
- iliac vein stenting and pelvic vein embolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to Mar 2025
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1) Female Patients 2) Child-baring period (18-50) 3) Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 4) Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- 5) CEAP Classification C 0,1,2
Who cannot join
- 1) Pregnancy 2) Breast-feeding 3) Menopause 4) Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 5) Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 6) CEAP Classification C 3,4,5
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions
Read the detailed description
- Type of Study: Prospective randomized 2 arms clinical trial
- Study Setting: Ain Shams University hospitals
- Study Period: 6 months
- Sample Size: 20 patients
- Study Population Female patients walking in or referred to the out-patient clinic at Ain Shams University Specialized Hospitals or El-Demerdash University Hospitals with symptoms of pelvic venous insufficiency.
- Inclusion Criteria:
- Female Patients
- Child-baring period (18-50)
- Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- CEAP Classification C 0,1,2
Exclusion Criteria:
- Pregnancy
- Breast-feeding
- Menopause
- Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- CEAP Classification C 3,4,5
- Sampling Method Convenient sample
- Ethical Considerations An informed consent will be taken from every patient prior to having the procedure to document having their approval for both, having the procedure and participating in the study with emphasis that their medical treatment will not be affected by their refusal of participation according to approved standards to ethical committee of Ain Shams University.
- Study Tools 20 patients will be randomly divided into 2 equal groups (A and B) Written informed consent. Full history taking with pelvic pain assessment (by onset, course, duration, site, character, radiation, aggravating and reliving factors, severity, timing, associated symptoms) and other pelvic symptoms, urinary symptoms or piles assessment guided by The Pelvic Venous Clinical Severity Score (PVCSS) giving the patient a score.
Clinical Assessment and examination of the patients including tenderness in left iliac fossa and vulvar varicosities, after exclusion of gynaecological causes confirmed by Gynaecology.
Full Lab investigations (complete blood count, coagulation profile, serum creatinine).
Radiological investigations:
- Combined pelviabdominal and transvaginal ultrasound to determine the diameter and the reflux of the ovarian veins, internal iliac veins and para uterine veins with diameter of ovarian vein > 6mm and para uterine vein > 5mm, also the criteria to diagnose Nonthrombotic iliac vein lesions with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- CT Venography. All patients will undergo Multiplaner venogram via ultrasound guided puncture through popliteal vein, Great Saphenous Vein (GSV), Common femoral vein to view the left common iliac vein and to view the pelvic escape points after cannulation of the left renal vein Group A patients will undergo left common iliac vein stenting according to diameter measurements using balloon-mounted stents.
Group B patients will undergo concomitant iliac vein stenting and embolization of pelvic veins by injection of left ovarian vein or parauterine veins pelvic escape points using sandwich technique of detachable or pushable coils and polidocanol 3 %.
Analysis of the results. Statistical Analysis: Collected data will be tabulated and analyzed using SPSS (IBM SPSS Statistics for Mac, Version 25.0. IBM Corp., Armonk, NY). Chi-square test and ANOVA will be used for categorical data, t-test will be used to compare mean values of non-categorical data between both groups, suitable graphs and figures will be plotted to demonstrate relevant statistics.
Primary end point:
Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)
- Being tested
- iliac vein stenting, pelvic vein embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iliac vein stentingProcedure or surgery
patients will undergo left common iliac vein stenting according to diameter measurements using balloon-mounted stents.
pelvic vein embolizationProcedure or surgery
embolization of pelvic veins by injection of left ovarian vein or parauterine veins pelvic escape points using sandwich technique of detachable or pushable coils and polidocanol 3 %.
| Study group | Role | What they receive |
|---|---|---|
| Isolated iliac vein stenting | Active comparator | Not described Receives: Procedure: iliac vein stenting |
| Concomitant iliac vein stenting with pelvic vein embolization | Active comparator | Not described Receives: Procedure: iliac vein stenting; Procedure: pelvic vein embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonthrombotic Iliac Vein LesionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdulrahman Salem, Study director, Professor of vascular surgery, faculty of medicine Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311669
- Sponsor's protocol ID
- 29409010104798
- Status last verified
- Dec 2023
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Isolated Iliac Vein Stenting Versus Concomitant Iliac Vein Stenting With Pelvic Vein Embolization in Patients With Pelvic Venous Insufficiency Secondary to Nonthrombotic Iliac Vein Lesions
- ClinicalTrials.gov ID
- NCT06311669
- Acronym / sponsor ID
- 29409010104798
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Mar 2024 (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 the study is to compare between Isolated Iliac vein stenting vs Concomitant Iliac vein stenting with pelvic vein embolization in patients with Pelvic Venous Insufficiency secondary to Nonthrombotic iliac vein lesions
Detailed description
- Type of Study: Prospective randomized 2 arms clinical trial
- Study Setting: Ain Shams University hospitals
- Study Period: 6 months
- Sample Size: 20 patients
- Study Population Female patients walking in or referred to the out-patient clinic at Ain Shams University Specialized Hospitals or El-Demerdash University Hospitals with symptoms of pelvic venous insufficiency.
- Inclusion Criteria:
- Female Patients
- Child-baring period (18-50)
- Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- CEAP Classification C 0,1,2
Exclusion Criteria:
- Pregnancy
- Breast-feeding
- Menopause
- Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017)
- CEAP Classification C 3,4,5
- Sampling Method Convenient sample
- Ethical Considerations An informed consent will be taken from every patient prior to having the procedure to document having their approval for both, having the procedure and participating in the study with emphasis that their medical treatment will not be affected by their refusal of participation according to approved standards to ethical committee of Ain Shams University.
- Study Tools 20 patients will be randomly divided into 2 equal groups (A and B) Written informed consent. Full history taking with pelvic pain assessment (by onset, course, duration, site, character, radiation, aggravating and reliving factors, severity, timing, associated symptoms) and other pelvic symptoms, urinary symptoms or piles assessment guided by The Pelvic Venous Clinical Severity Score (PVCSS) giving the patient a score.
Clinical Assessment and examination of the patients including tenderness in left iliac fossa and vulvar varicosities, after exclusion of gynaecological causes confirmed by Gynaecology.
Full Lab investigations (complete blood count, coagulation profile, serum creatinine).
Radiological investigations:
- Combined pelviabdominal and transvaginal ultrasound to determine the diameter and the reflux of the ovarian veins, internal iliac veins and para uterine veins with diameter of ovarian vein > 6mm and para uterine vein > 5mm, also the criteria to diagnose Nonthrombotic iliac vein lesions with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- CT Venography. All patients will undergo Multiplaner venogram via ultrasound guided puncture through popliteal vein, Great Saphenous Vein (GSV), Common femoral vein to view the left common iliac vein and to view the pelvic escape points after cannulation of the left renal vein Group A patients will undergo left common iliac vein stenting according to diameter measurements using balloon-mounted stents.
Group B patients will undergo concomitant iliac vein stenting and embolization of pelvic veins by injection of left ovarian vein or parauterine veins pelvic escape points using sandwich technique of detachable or pushable coils and polidocanol 3 %.
Analysis of the results. Statistical Analysis: Collected data will be tabulated and analyzed using SPSS (IBM SPSS Statistics for Mac, Version 25.0. IBM Corp., Armonk, NY). Chi-square test and ANOVA will be used for categorical data, t-test will be used to compare mean values of non-categorical data between both groups, suitable graphs and figures will be plotted to demonstrate relevant statistics.
Primary end point:
Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated iliac vein stenting | Active comparator | Procedure: iliac vein stenting |
| Concomitant iliac vein stenting with pelvic vein embolization | Active comparator | Procedure: iliac vein stenting, Procedure: pelvic vein embolization |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1) Female Patients 2) Child-baring period (18-50) 3) Patients with type 2 Pelvic congestion (defined as venous substitute pathology secondary to stenosis or obstruction in a draining vein according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 4) Patients with Nonthrombotic iliac vein lesions confirmed by Duplex with Peak Systolic Velocity (PSV) ratio between stenotic and pre stenotic segment > 2.5.
- 5) CEAP Classification C 0,1,2
Key exclusion criteria (1 listed)
- 1) Pregnancy 2) Breast-feeding 3) Menopause 4) Patients with type 1 Pelvic congestion (defined as reflux pathology secondary to valvular or parietal venous anomaly without pelvic or supra-pelvic obstruction to venous flow according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 5) Patients with type 3 Pelvic congestion (defined as local extrinsic cause responsible for pelvic venous anomaly according to Greiner classification of pelvic congestion) (Milka Greiner., et al 2017) 6) CEAP Classification C 3,4,5
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 |
|---|---|---|
| iliac vein stentingpatients will undergo left common iliac vein stenting according to diameter measurements using balloon-mounted stents. | Procedure or surgery | Concomitant iliac vein stenting with pelvic vein embolization, Isolated iliac vein stenting |
| pelvic vein embolizationembolization of pelvic veins by injection of left ovarian vein or parauterine veins pelvic escape points using sandwich technique of detachable or pushable coils and polidocanol 3 %. | Procedure or surgery | Concomitant iliac vein stenting with pelvic vein embolization |
Primary outcome
Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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.
Abdulrahman Salem study director
Professor of vascular surgery, faculty of medicine Ainshams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iliac vein stenting and pelvic vein embolization in people with Nonthrombotic Iliac Vein Lesions and Pelvic Congestive Syndrome, run by Ain Shams University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Egypt. 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?
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 improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS) (time frame: 6 months). 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 15 Mar 2024.