AI-Based Prediction Model for Iliofemoral DVT Thrombolysis

NCT07181083 | Active Not Recruiting

• 1 other identifier: IR.RHC.REC.1403.013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-arm cohort study aims to develop an AI-powered prediction model for treatment outcomes in patients with acute extensive iliofemoral deep vein thrombosis (IF-DVT) undergoing stent-free pharmacomechanical thrombolysis. The study addresses the current lack of validated tools for patient selection and outcome prediction in catheter-directed interventions for proximal DVT. Thirty consecutive adult patients with MRV-confirmed acute IF-DVT will undergo pharmacomechanical thrombolysis using the AngioJet ZelanteDVT system with adjunctive rtPA administration. The primary objective is to develop a convolutional neural network (CNN) trained on serial MRV imaging data to predict three-month venous recanalization success. MRV acquisitions occur at baseline, predischarge, and three-month follow-up. Ground truth segmentation will be performed by an experienced radiologist using 3D Slicer, with semi-automated propagation across the dataset. Feature extraction will include geometric metrics, radiomic texture analysis, and morphological characteristics of both thrombus and vessel architecture. Secondary endpoints include acute kidney injury incidence (a significant concern with rheolytic thrombectomy due to hemolysis-induced nephrotoxicity), post-thrombotic syndrome development assessed via Villalta scoring, and various safety outcomes including major bleeding per ISTH criteria. The study protocol incorporates rigorous monitoring for AKI using KDIGO criteria, with systematic evaluation of renal function, hemolysis markers, and electrolyte balance. Hydration protocols and nephroprotective measures will be standardized, though specific strategies require clarification from the nephrology team. This research addresses critical gaps in evidence-based patient selection for invasive DVT treatment, particularly following the mixed results of the ATTRACT trial. The AI prediction model could enable personalized treatment decisions, potentially improving the risk-benefit ratio of pharmacomechanical interventions while reducing unnecessary procedures in patients unlikely to benefit.

Conditions

Deep Vein Thrombosis of the Lower Extremities

Keywords

Deep vein thrombosis; Prediction model; Iliofemoral vein; Pharmacomechanical thrombolysis; Magnetic resonance venography; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• During the procedure

  The extent of venous recanalization after stent-free pharmacomechanical thrombolysis as assessed by magnetic resonance venography at three months post-procedure. Recanalization will be graded as: Grade 0 (no flow/complete occlusion), Grade 1 (minimal flow with ≤25% lumen patency), Grade 2 (partial flow with 26-75% patency), or Grade 3 (near-complete flow with \>75% patency). Treatment success is defined as achieving Grade 2 or 3 recanalization.

  3 months post-procedure

Secondary Outcomes (15)

• MRV-based Predischarge Venous Recanalization

  At hospital discharge (typically 3-7 days post-procedure)

• At hospital discharge (typically 3-7 days post-procedure)

  3 months post-procedure

• MRV-based Predischarge Percentage Reduction in Thrombus Volume

  At hospital discharge (typically 3-7 days post-procedure)

• Postprocedural Acute Kidney Injury Occurrence

  During index hospitalization (typically 3-7 days)

• Need for New Renal Replacement Therapy

  During index hospitalization (typically 3-7 days)

Study Arms (1)

Extensive iliofemoral DVT

Patients with extensive ioliofemoral DVT candidate for pharmaco-mechanical thrombectomy

Device: Rheolytic thrombectomy

Interventions

Rheolytic thrombectomy DEVICE

Rheolytic thrombectomy via AngioJet ZelanteDVTTM Catheter (Boston Scientific Co., USA).

Extensive iliofemoral DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from adult patients aged 18 years and older of both sexes presenting to the Rajaie Cardiovascular Medical and Research Institute, a tertiary referral cardiovascular center in Tehran, Iran, with acute symptomatic iliofemoral deep vein thrombosis.

You may qualify if:

• All consecutive adult (≥18 years) patients with an MRV-based diagnosis of acute IF- DVT
• Symptomatic patients with severe pain and\\or leg swelling more than 5 cm
• Willing to participate in the study

You may not qualify if:

• Previous history of VTE
• Presence of DVT syndrome for more than 21 days
• Terminal systemic disease requiring palliative treatment
• Active bleeding
• History of hemorrhagic stroke
• Major fibrinolytic contraindication
• Any hereditary coagulopathy disorders
• Patients with baseline renal dysfunction with an estimated glomerular filtration rate (eGFR) of \< 60 ml/min/1.73m2 due to Cockroft-Gault formula based on the creatinine level at the time of admission
• Having any underlying condition that makes the patient unsuitable for MRV and/or rheolytic thrombectomy procedure (e.g., allergy to contrast agent, claustrophobia)
• Having any underlying disabling condition that necessitates a prolonged complete bed rest prohibiting early ambulation

Sponsors & Collaborators

• Rajaie Cardiovascular Medical and Research Center: lead

Study Sites (1)

Rajaie Cardiovascular Medical and Research Institute

Tehran, Tehran Province, 1995614331, Iran

Location

MeSH Terms

Conditions

Venous Thrombosis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

IR (1)