Deep Vein Thrombosis of the Lower Extremities
Conditions
Keywords
Deep vein thrombosis, Prediction model, Iliofemoral vein, Pharmacomechanical thrombolysis, Magnetic resonance venography, Acute kidney injury
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.
Interventions
DEVICERheolytic thrombectomy
Rheolytic thrombectomy via AngioJet ZelanteDVTTM Catheter (Boston Scientific Co., USA).
Sponsors
Rajaie Cardiovascular Medical and Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| During the procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| MRV-based Predischarge Venous Recanalization | 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) |
| At hospital discharge (typically 3-7 days post-procedure) | 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 |
| MRV-based Predischarge Percentage Reduction in Thrombus Volume | 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 |
| Major Bleeding Events | 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. |
| Postprocedural Acute Kidney Injury Occurrence | 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. |
| Need for New Renal Replacement Therapy | 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. |
| Postprocedural Oliguria or Anuria | 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. |
| Postprocedural Gross Hematuria | 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. |
| Three-month Recurrent Venous Thromboembolism | 3 months post-procedure | Objectively confirmed recurrent symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) during the three-month follow-up period. |
| Three-month Post-thrombotic Syndrome Incidence | 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). |
| Three-month Post-thrombotic Syndrome Severity | 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). |
| In-hospital All-cause Mortality | During index hospitalization (typically 3-7 days) | Death from any cause during the index hospitalization period. |
| Three-month All-cause Mortality | 3 months post-procedure | Death from any cause during the three-month follow-up period. |
| Technical Success Rate | During the procedure | Successful placement of the AngioJet device catheter and initiation of the thrombectomy procedure as intended per protocol. |
| Postprocedural Hyperkalemia | 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. |
Countries
Iran
Outcome results
None listed