Deep Vein Thrombosis of the Lower ExtremitiesNCT07181083
AI-Based Prediction Model for Iliofemoral DVT Thrombolysis
An observational study of Deep Vein Thrombosis of the Lower Extremities, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis of the Lower Extremities
- What is being tested?
- Rheolytic thrombectomy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2024to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rajaie Cardiovascular Medical and Research Institute
Tehran, Tehran Province, 1995614331
About this study
Official title: Imaging-based Prediction of Stent-free Pharmaco-mechanical Thrombolysis in Patients With Extensive Acute Ilio-femoral Deep Vein Thrombosis
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.
Read more
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.
- Being tested
- Rheolytic thrombectomy
- Keywords
- Deep vein thrombosis, Prediction model, Iliofemoral vein, Pharmacomechanical thrombolysis, Magnetic resonance venography, Acute kidney injury
- Medical subject headings
- Venous Thrombosis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheolytic thrombectomyDevice
Rheolytic thrombectomy via AngioJet ZelanteDVTTM Catheter (Boston Scientific Co., USA).
| Study group | Role | What they receive |
|---|---|---|
| Extensive iliofemoral DVT | Patients with extensive ioliofemoral DVT candidate for pharmaco-mechanical thrombectomy Receives: Device: Rheolytic thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-procedure
Secondary outcomes (15)
MRV-based Predischarge Venous Recanalization
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)
Measured: At hospital discharge (typically 3-7 days post-procedure)
At hospital discharge (typically 3-7 days 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
Measured: 3 months post-procedure
MRV-based Predischarge Percentage Reduction in Thrombus Volume
Quantified thrombus volume reduction from baseline to hospital discharge as measured by magnetic resonance venography, with meaningful reduction defined as ≥50% volume decrease
Measured: At hospital discharge (typically 3-7 days post-procedure)
Postprocedural Acute Kidney Injury Occurrence
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.
Measured: During index hospitalization (typically 3-7 days)
Need for New Renal Replacement Therapy
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.
Measured: During index hospitalization (typically 3-7 days)
Postprocedural Oliguria or Anuria
Development of oliguria (urine output <0.5 mL/kg/hour) or anuria (urine output <50 mL/day) during the index hospitalization period.
Measured: During index hospitalization (typically 3-7 days)
Postprocedural Hyperkalemia
Elevated serum potassium concentration above normal limits (>5.0-5.5 mEq/L) during the index hospitalization period.
Measured: During index hospitalization (typically 3-7 days)
Postprocedural Gross Hematuria
Presence of visible blood in urine detected by visual inspection or urine testing during the index hospitalization period.
Measured: During index hospitalization (typically 3-7 days)
Major Bleeding Events
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.
Measured: During index hospitalization (typically 3-7 days)
Three-month Recurrent Venous Thromboembolism
Objectively confirmed recurrent symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) during the three-month follow-up period.
Measured: 3 months post-procedure
Three-month Post-thrombotic Syndrome Incidence
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).
Measured: 3 months post-procedure
Three-month Post-thrombotic Syndrome Severity
Severity classification of post-thrombotic syndrome using Villalta score: mild (5-9), moderate (10-14), or severe (≥15 or venous ulceration).
Measured: 3 months post-procedure
In-hospital All-cause Mortality
Death from any cause during the index hospitalization period.
Measured: During index hospitalization (typically 3-7 days)
Three-month All-cause Mortality
Death from any cause during the three-month follow-up period.
Measured: 3 months post-procedure
Technical Success Rate
Successful placement of the AngioJet device catheter and initiation of the thrombectomy procedure as intended per protocol.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis of the Lower ExtremitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajaie Cardiovascular Medical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parham Sadeghipour, Rajaie Cardiovascular Medical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181083
- Sponsor's protocol ID
- IR.RHC.REC.1403.013
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-based Prediction of Stent-free Pharmaco-mechanical Thrombolysis in Patients With Extensive Acute Ilio-femoral Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT07181083
- Acronym / sponsor ID
- IR.RHC.REC.1403.013
- Keywords
- Deep vein thrombosis, Prediction model, Iliofemoral vein, Pharmacomechanical thrombolysis, Magnetic resonance venography, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rajaie Cardiovascular Medical and Research CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extensive iliofemoral DVT | – | Device: Rheolytic thrombectomyPatients with extensive ioliofemoral DVT candidate for pharmaco-mechanical thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheolytic thrombectomyRheolytic thrombectomy via AngioJet ZelanteDVTTM Catheter (Boston Scientific Co., USA). | Device | Extensive iliofemoral DVT |
Primary outcome
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.
15 secondary outcomes
MRV-based Predischarge Venous Recanalization
Time frame: At hospital discharge (typically 3-7 days post-procedure)
At hospital discharge (typically 3-7 days post-procedure)
Time frame: 3 months post-procedure
MRV-based Predischarge Percentage Reduction in Thrombus Volume
Time frame: At hospital discharge (typically 3-7 days post-procedure)
Postprocedural Acute Kidney Injury Occurrence
Time frame: During index hospitalization (typically 3-7 days)
Need for New Renal Replacement Therapy
Time frame: During index hospitalization (typically 3-7 days)
Postprocedural Oliguria or Anuria
Time frame: During index hospitalization (typically 3-7 days)
Postprocedural Hyperkalemia
Time frame: During index hospitalization (typically 3-7 days)
Postprocedural Gross Hematuria
Time frame: During index hospitalization (typically 3-7 days)
Major Bleeding Events
Time frame: During index hospitalization (typically 3-7 days)
Three-month Recurrent Venous Thromboembolism
Time frame: 3 months post-procedure
Three-month Post-thrombotic Syndrome Incidence
Time frame: 3 months post-procedure
Three-month Post-thrombotic Syndrome Severity
Time frame: 3 months post-procedure
In-hospital All-cause Mortality
Time frame: During index hospitalization (typically 3-7 days)
Three-month All-cause Mortality
Time frame: 3 months post-procedure
Technical Success Rate
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis of the Lower Extremities, run by Rajaie Cardiovascular Medical and Research Center at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
During the procedure (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.