Status:

ACTIVE_NOT_RECRUITING

AI-Based Prediction Model for Iliofemoral DVT Thrombolysis

Lead Sponsor:

Rajaie Cardiovascular Medical and Research Center

Conditions:

Deep Vein Thrombosis of the Lower Extremities

Eligibility:

All Genders

18+ years

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 ste...

Eligibility Criteria

Inclusion

  • 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

  • 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
  • Low-quality MRV imaging or motion artifact (exclusion criteria for the imaging sub-studies)

Key Trial Info

Start Date :

July 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2025

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07181083

Start Date

July 1 2024

End Date

October 1 2025

Last Update

September 18 2025

Active Locations (1)

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Rajaie Cardiovascular Medical and Research Institute

Tehran, Tehran Province, Iran, 1995614331