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

NCT06311669 | Unknown

• 1 other identifier: 29409010104798
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nonthrombotic Iliac Vein Lesions; Pelvic Congestive Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical improvement of pain and pelvic symptoms according to the Pelvic Venous Clinical Severity Score (PVCSS)

  6 months

Study Arms (2)

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

Interventions

iliac vein stenting PROCEDURE

patients will undergo left common iliac vein stenting according to diameter measurements using balloon-mounted stents.

Concomitant iliac vein stenting with pelvic vein embolization; Isolated iliac vein stenting

pelvic vein embolization PROCEDURE

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 %.

Concomitant iliac vein stenting with pelvic vein embolization

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• \) CEAP Classification C 0,1,2

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

Study Officials

• Abdulrahman Salem

  Professor of vascular surgery, faculty of medicine Ainshams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2023-12

Locations

EG (1)