AI-Based Prediction Model for Iliofemoral DVT Thrombolysis

NCT ID: NCT07181083

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Extensive iliofemoral DVT

Patients with extensive ioliofemoral DVT candidate for pharmaco-mechanical thrombectomy

Rheolytic thrombectomy

Intervention Type: DEVICE

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

Interventions

Rheolytic thrombectomy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rajaie Cardiovascular Medical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Parham Sadeghipour

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rajaie Cardiovascular Medical and Research Institute

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

IR.RHC.REC.1403.013

Identifier Type: -

Identifier Source: org_study_id