AI may help decide who benefits from Clot-Busting procedure
NCT ID NCT07181083
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether an AI model can predict if a clot-removal procedure will work for people with severe deep vein thrombosis (DVT) in the leg. Thirty adults will receive a catheter-based treatment that breaks up and removes clots, and the AI will analyze MRI scans to see if it can forecast recovery. The goal is to help doctors avoid giving this invasive treatment to patients who are unlikely to benefit, reducing risks like kidney damage and bleeding.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rtPA (a clot-dissolving drug) delivered via the AngioJet ZelanteDVT catheter
- What this could lead to
- If successful, this AI model could help doctors choose which patients with deep vein thrombosis will benefit most from clot-removal procedures, avoiding unnecessary risks.
- What could go wrong
- This is a small, early study with only 30 participants, so the AI model may not work well for all patients. The procedure itself carries risks like kidney injury and bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
30 people
The number who actually took part.
- Started
-
Jul 2024
- Expected to finish
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Oct 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rajaie Cardiovascular Medical and Research Institute
Tehran, Tehran Province, 1995614331, Iran