Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07181083

AI-Based Prediction Model for Iliofemoral DVT Thrombolysis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Deep Vein Thrombosis of the Lower Extremities Acute Kidney Injury Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rajaie Cardiovascular Medical and Research Institute

Tehran, Tehran Province, 1995614331, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rheolytic thrombectomy

Device

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

Primary outcomes

  1. During the procedure

    Time frame: 3 months post-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.

Secondary outcomes

  1. MRV-based Predischarge Venous Recanalization

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

    The extent of venous recanalization in the acute phase after stent-free pharmacomechanical thrombolysis as measured by magnetic resonance venography, classified as complete (>90% clearance), nearly complete (50-90% clearance), or partial (<50% resolution)

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

    Time frame: 3 months post-procedure

    Quantified thrombus volume reduction from baseline to three-month follow-up as measured by magnetic resonance venography, with meaningful reduction defined as ≥50% volume decrease

  3. MRV-based Predischarge Percentage Reduction in Thrombus Volume

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

    Quantified thrombus volume reduction from baseline to hospital discharge as measured by magnetic resonance venography, with meaningful reduction defined as ≥50% volume decrease

  4. Postprocedural Acute Kidney Injury Occurrence

    Time frame: During index hospitalization (typically 3-7 days)

    Development of acute kidney injury during hospitalization based on KDIGO criteria: ≥0.3 mg/dL increase in serum creatinine within 48 hours, ≥1.5x baseline creatinine increase, or urine output <0.5 mL/kg/h for 6 hours.

  5. Need for New Renal Replacement Therapy

    Time frame: During index hospitalization (typically 3-7 days)

    Requirement for initiation of any form of renal replacement therapy (hemodialysis, continuous veno-venous hemofiltration, peritoneal dialysis) due to acute kidney injury in patients without previous dialysis history.

  6. Postprocedural Oliguria or Anuria

    Time frame: During index hospitalization (typically 3-7 days)

    Development of oliguria (urine output <0.5 mL/kg/hour) or anuria (urine output <50 mL/day) during the index hospitalization period.

  7. Postprocedural Hyperkalemia

    Time frame: During index hospitalization (typically 3-7 days)

    Elevated serum potassium concentration above normal limits (>5.0-5.5 mEq/L) during the index hospitalization period.

  8. Postprocedural Gross Hematuria

    Time frame: During index hospitalization (typically 3-7 days)

    Presence of visible blood in urine detected by visual inspection or urine testing during the index hospitalization period.

  9. Major Bleeding Events

    Time frame: During index hospitalization (typically 3-7 days)

    Major bleeding according to International Society of Thrombosis and Haemostasis (ISTH) definition: fatal bleeding, bleeding in critical organs, or bleeding causing ≥2.0 g/dL hemoglobin decrease or requiring ≥2 units red blood cell transfusion.

  10. Three-month Recurrent Venous Thromboembolism

    Time frame: 3 months post-procedure

    Objectively confirmed recurrent symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) during the three-month follow-up period.

  11. Three-month Post-thrombotic Syndrome Incidence

    Time frame: 3 months post-procedure

    Development of post-thrombotic syndrome defined as Villalta score ≥5, assessed through standardized evaluation of symptoms (pain, cramps, heaviness, paresthesia, pruritus) and clinical signs (edema, induration, hyperpigmentation, redness, venous ectasia, calf pain on compression).

  12. Three-month Post-thrombotic Syndrome Severity

    Time frame: 3 months post-procedure

    Severity classification of post-thrombotic syndrome using Villalta score: mild (5-9), moderate (10-14), or severe (≥15 or venous ulceration).

  13. In-hospital All-cause Mortality

    Time frame: During index hospitalization (typically 3-7 days)

    Death from any cause during the index hospitalization period.

  14. Three-month All-cause Mortality

    Time frame: 3 months post-procedure

    Death from any cause during the three-month follow-up period.

  15. Technical Success Rate

    Time frame: During the procedure

    Successful placement of the AngioJet device catheter and initiation of the thrombectomy procedure as intended per protocol.

Sponsors and collaborators

Lead sponsor

Rajaie Cardiovascular Medical and Research Center

Other

Registry information

Official study title

Imaging-based Prediction of Stent-free Pharmaco-mechanical Thrombolysis in Patients With Extensive Acute Ilio-femoral Deep Vein Thrombosis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.