Deep Venous ThrombosisPhase 4NCT06486181
Second Line Endovascular Treatment in Acute DVT
A Phase 4 study testing Thrombolysis/Thrombectomy in people with Deep Venous Thrombosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to fill the paucity of second line endovascular treatment for acute deep venous thrombus (DVT) by using catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Thrombolysis/Thrombectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Apr 2029
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus
- Patients eligible for anticoagulation treatment
Who cannot join
- Patients under 18 years of age
- Patients over 75 years of age
- Symptoms starting date of more than 14 days
- Patients who have contraindication for anticoagulation treatment
- Patients who have high bleeding risk (more than 2 of the following risk factors):
- Age >65 years
Show all 22Show fewer
- Previous bleeding
- Cancer
- Metastatic cancer
- Renal failure
- Liver failure
- Thrombocytopenia
- Previous stroke
- Diabetes
- Anemia
- Antiplatelet therapy
- Poor anticoagulant control
- Comorbidity and reduced functional capacity
- Recent surgery in 30 days
- Frequent falls
- Hemodynamically unstable patients
- Patients having severe swelling and pain, cyanosis, and absent pulses consistent with compartment syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
RUSH University Medical Center
Chicago, Illinois, 60612
Okan Ince, MD, 312-947-2508, Okan_Ince@rush.edu
Emerald Amos, MS, 312-947-2518, Emerald_Amos@rush.edu
About this study
Official title: A Randomized Controlled Trial for Second Line Treatment of Acute DVT With Endovascular Interventional Treatments
The goal of this study is to fill the paucity of second line endovascular treatment for acute deep venous thrombus (DVT) by using catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation trial for one week. The main questions the study aims to answer are:
- Are adjunctive use of endovascular interventional treatments as second-line to DVT treatment safe and efficient?
Participants will be followed with repeat US at 1 week after initial DVT to assess for response to anticoagulation treatment. If there is significant residual thrombus with minimal or no response to treatment, participants will be offered enrollment to the study in the office or inpatient setting. Enrolled participants will be randomized into control or intervention arms with 1:1 ratio. Researchers will compare follow-up Villalta and Marder scores between groups to see whether endovascular interventions are safe and efficient.
Read the detailed description
The incidence of deep vein thrombosis (DVT) annually is documented to be between 45 and 117 cases per 100,000 individuals. The disease markedly impairs patient well-being, leading to symptoms such as pain, limb edema, diminished mobility, and the development of cutaneous ulcers. The spectrum of DVT-associated complications is broad, encompassing post-thrombotic syndrome (PTS) in up to 56% of patients [1] , pulmonary embolism (PE) in an estimated 15% to 32%, and a recurrence rate of DVT within one year in approximately 22% of cases [2] . Survival metrics for DVT patients indicate a survival probability of 85.4% at one-year post-diagnosis, declining to 72.6% at the five-year mark in epidemiologic studies [3] . A large prospective cohort study showed that patients with acute iliofemoral DVT have 2.4 times more likely increased of recurrences compared to less extensive disease [4] . Another study showed increased risk of developing PTS alongside increased severity in patients with acute iliofemoral DVT rather than patients less extensive thrombus burden [5, 6] .
Although the standard treatment for acute DVT is anticoagulation, the role of endovascular therapies has significantly increased. With the FDA clearance of devices for catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT), a recent claims analysis of Centers for Medicare and Medicaid Services beneficiaries documented a boost in endovascular treatment of acute DVT [7] . However, further data is needed to assess the long-term efficacy of endovascular treatment.
The ATTRACT trial, a randomized controlled trial comparing CDT with anticoagulation treatment for acute DVT, was a recent large-scale trial with a sample size of 692 [8] . The trial showed no benefit of CDT in preventing PTS over two years (47% vs. 48%, p = 0.56). However, the ATTRACT trial demonstrated significant improvement in early symptoms within 30 days in CDT arm (p = 0.001). Moreover, CDT treatment was shown to reduce the occurrence of moderate or severe PTS (18% vs. 28%, p = 0.02) with reducing severity of PTS as well (mean differences 1.6 in Villalta Scores between groups, p = 0.001).
One of the setbacks of the ATTRACT trial is that the devices used in the study are no longer in current practice (Trellis), or have been modified (AngioJet), and the direct oral anticoagulant (DOAC) agents, widely used in current practice, were not included in the study. The titration of warfarin is challenging and could be impacted by various parameters. With the rapid developments in health care technology, endovascular treatments of DVT are now performed more safely and efficiently. Additionally, Many new large bore thrombectomy devices with more advanced clot removal components received FDA clearance for use in acute and subacute DVT treatment [9-12] . With these new advancements in patient care, further data reflecting contemporary practice is needed.
The current Society of Interventional Radiology (SIR) guidelines for the management of acute DVT suggest that adjunctive CDT should be considered for patients who continue to have moderate-severe symptoms or impaired ambulation despite an initial anticoagulation trial [13] . This implies that CDT could be a second-line treatment, for which data is limited to non-randomized studies and expert consensus. Also, in routine care of the patients many clinicians fail to obtain a 1 week follow up US to confirm efficacy of the systemic anticoagulation. They rely on patient symptoms and patients have different thresholds for communicating their symptoms to their physicians which may lead to delayed care and potential loss of efficient endovascular therapeutic window.
This randomized controlled study aims to fill this gap by using CDT and MT as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation trial for one week.
As per the standard of care all patients diagnosed with acute iliofemoral DVT are being seen in IR clinic 1 week after (+/- 3 days) the first notification to DVT team which is covered by IR 24/7, to assess the improvement after initial anticoagulation trial.
During the clinic visit a venous duplex ultrasound imaging is performed to assess the thrombus burden compared to initial presentation. After the US study, clinical evaluation will be performed using Marder Score and Villalta Score systems. Patients who failed to improve after initial anticoagulation treatment will be offered enrollment to the study.
After enrollment, patients will be randomized with 1:1 ratio by a web-based randomization tool.
Control Arm:
Control arm will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed.
Intervention Arm:
Patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms.
Patients' post-procedural Villalta scores and Marder Scores of pre/post-procedure venography and duplex ultrasound will be recorded at discharge.
Crossover To Intervention Arm:
Crossover from control arm to intervention arm will be considered when following conditions occur:
- Clinical and/or imaging deterioration according to Villalta/Marder score systems.
- Symptoms suggesting arterial vascular compromise
- Development of new acute thrombus under anticoagulation
- Conditions
- Deep Venous Thrombosis
- Being tested
- Thrombolysis/Thrombectomy
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombolysis/ThrombectomyOther
Endovascular interventions will be either catheter directed thrombolysis or mechanical thrombectomy procedures both of which have been cleared by FDA for the treatment of acute DVT.
Catheter-directed thrombolysis involves the use of a catheter to deliver thrombolytic agents directly to the site of the clot, effectively dissolving the thrombus. Mechanical thrombectomy, on the other hand, employs specialized devices to physically remove the clot from the vessel. These procedures have been cleared by FDA as they are targeted approaches to safely and effectively restore blood flow and reduce the risk of complications associated with acute DVT.
| Study group | Role | What they receive |
|---|---|---|
| Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulation | No intervention | Patients presenting to emergency department with the following criteria: over 18 years of age, who have diagnosis of acute femoropopliteal acute deep venous thrombus, placed on anticoagulation treatment and failed to resolve the DVT in 1 week (+/- 3 days) follow up Doppler US study. In control arm the treatment will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed. |
| Unresolved Deep Venous Thrombosis Patients managed by interventional therapies. | Experimental | Patients presenting to emergency department with the following criteria:
over 18 years of age, who have diagnosis of acute femoropopliteal acute deep venous thrombus, placed on anticoagulation treatment and failed to resolve the DVT in 1 week (+/- 3 days) follow up Doppler US study. In intervention arm, patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms. Receives: Other: Thrombolysis/Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease
The scores will be compared between arms at the end of the study.
Measured: 30 days
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease
The scores will be compared between arms at the end of the study.
Measured: 90 days
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease
The scores will be compared between arms at the end of the study.
Measured: 180 days
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease
The scores will be compared between arms at the end of the study.
Measured: 12 months
Efficacy of Endovascular Treatments Sonographically
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.
The scores will be compared between arms at the end of the study.
Measured: 30 days
Efficacy of Endovascular Treatments Sonographically
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.
The scores will be compared between arms at the end of the study.
Measured: 90 days
Efficacy of Endovascular Treatments Sonographically
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.
The scores will be compared between arms at the end of the study.
Measured: 180 days
Efficacy of Endovascular Treatments Sonographically
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.
The scores will be compared between arms at the end of the study.
Measured: 12 months
Secondary outcomes (1)
Safety of Endovascular Treatments
Any adverse events occurred within 30 days of procedure will be reviewed and categorized by the current Society of Interventional Radiology guidelines.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After enrollment, patients will be randomized with 1:1 ratio by a web-based randomization tool. Control Arm: Control arm will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed. Intervention Arm: Patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms. Patients' post-procedural Villalta scores and Marder Scores of pre/post-procedure venography and duplex ultrasound will be recorded at discharge.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Arslan, Rush University Medical Center
- Investigators
- Bulent Arslan, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486181
- Sponsor's protocol ID
- 24020105
- Status last verified
- Jan 2026
- First submitted
- 29 Apr 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will be accessible only to the research staff who perform the statistical analysis.
Publications
Kucher N. Clinical practice. Deep-vein thrombosis of the upper extremities. N Engl J Med. 2011 Mar 3;364(9):861-9. doi: 10.1056/NEJMcp1008740. No abstract available.
PubMed 21366477Owens CA, Bui JT, Knuttinen MG, Gaba RC, Carrillo TC. Pulmonary embolism from upper extremity deep vein thrombosis and the role of superior vena cava filters: a review of the literature. J Vasc Interv Radiol. 2010 Jun;21(6):779-87. doi: 10.1016/j.jvir.2010.02.021.
PubMed 20434365Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.
PubMed 26780736Notten P, Ten Cate-Hoek AJ, Arnoldussen CWKP, Strijkers RHW, de Smet AAEA, Tick LW, van de Poel MHW, Wikkeling ORM, Vleming LJ, Koster A, Jie KG, Jacobs EMG, Ebben HP, Coppens M, Toonder I, Ten Cate H, Wittens CHA. Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial. Lancet Haematol. 2020 Jan;7(1):e40-e49. doi: 10.1016/S2352-3026(19)30209-1. Epub 2019 Nov 27.
PubMed 31786086Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
PubMed 30586751Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
PubMed 26853645Von Ende E, Gayou EL, Chick JFB, Makary MS. Nationwide Trends in Catheter-Directed Therapy Utilization for the Treatment of Lower Extremity Deep Vein Thrombosis in Medicare Beneficiaries. J Vasc Interv Radiol. 2021 Nov;32(11):1576-1582.e1. doi: 10.1016/j.jvir.2021.08.002. Epub 2021 Aug 17.
PubMed 34416368Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.
PubMed 29211671Vedantham S, Desai KR, Weinberg I, Marston W, Winokur R, Patel S, Kolli KP, Azene E, Nelson K. Society of Interventional Radiology Position Statement on the Endovascular Management of Acute Iliofemoral Deep Vein Thrombosis. J Vasc Interv Radiol. 2023 Feb;34(2):284-299.e7. doi: 10.1016/j.jvir.2022.10.038. Epub 2022 Nov 11.
PubMed 36375763
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Second Line Treatment of Acute DVT With Endovascular Interventional Treatments
- ClinicalTrials.gov ID
- NCT06486181
- Acronym / sponsor ID
- 24020105
- Conditions
- Deep Venous Thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 3 Jul 2024 (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.
The goal of this study is to fill the paucity of second line endovascular treatment for acute deep venous thrombus (DVT) by using catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation trial for one week. The main questions the study aims to answer are:
- Are adjunctive use of endovascular interventional treatments as second-line to DVT treatment safe and efficient?
Participants will be followed with repeat US at 1 week after initial DVT to assess for response to anticoagulation treatment. If there is significant residual thrombus with minimal or no response to treatment, participants will be offered enrollment to the study in the office or inpatient setting. Enrolled participants will be randomized into control or intervention arms with 1:1 ratio. Researchers will compare follow-up Villalta and Marder scores between groups to see whether endovascular interventions are safe and efficient.
Detailed description
The incidence of deep vein thrombosis (DVT) annually is documented to be between 45 and 117 cases per 100,000 individuals. The disease markedly impairs patient well-being, leading to symptoms such as pain, limb edema, diminished mobility, and the development of cutaneous ulcers. The spectrum of DVT-associated complications is broad, encompassing post-thrombotic syndrome (PTS) in up to 56% of patients [1] , pulmonary embolism (PE) in an estimated 15% to 32%, and a recurrence rate of DVT within one year in approximately 22% of cases [2] . Survival metrics for DVT patients indicate a survival probability of 85.4% at one-year post-diagnosis, declining to 72.6% at the five-year mark in epidemiologic studies [3] . A large prospective cohort study showed that patients with acute iliofemoral DVT have 2.4 times more likely increased of recurrences compared to less extensive disease [4] . Another study showed increased risk of developing PTS alongside increased severity in patients with acute iliofemoral DVT rather than patients less extensive thrombus burden [5, 6] .
Although the standard treatment for acute DVT is anticoagulation, the role of endovascular therapies has significantly increased. With the FDA clearance of devices for catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT), a recent claims analysis of Centers for Medicare and Medicaid Services beneficiaries documented a boost in endovascular treatment of acute DVT [7] . However, further data is needed to assess the long-term efficacy of endovascular treatment.
The ATTRACT trial, a randomized controlled trial comparing CDT with anticoagulation treatment for acute DVT, was a recent large-scale trial with a sample size of 692 [8] . The trial showed no benefit of CDT in preventing PTS over two years (47% vs. 48%, p = 0.56). However, the ATTRACT trial demonstrated significant improvement in early symptoms within 30 days in CDT arm (p = 0.001). Moreover, CDT treatment was shown to reduce the occurrence of moderate or severe PTS (18% vs. 28%, p = 0.02) with reducing severity of PTS as well (mean differences 1.6 in Villalta Scores between groups, p = 0.001).
One of the setbacks of the ATTRACT trial is that the devices used in the study are no longer in current practice (Trellis), or have been modified (AngioJet), and the direct oral anticoagulant (DOAC) agents, widely used in current practice, were not included in the study. The titration of warfarin is challenging and could be impacted by various parameters. With the rapid developments in health care technology, endovascular treatments of DVT are now performed more safely and efficiently. Additionally, Many new large bore thrombectomy devices with more advanced clot removal components received FDA clearance for use in acute and subacute DVT treatment [9-12] . With these new advancements in patient care, further data reflecting contemporary practice is needed.
The current Society of Interventional Radiology (SIR) guidelines for the management of acute DVT suggest that adjunctive CDT should be considered for patients who continue to have moderate-severe symptoms or impaired ambulation despite an initial anticoagulation trial [13] . This implies that CDT could be a second-line treatment, for which data is limited to non-randomized studies and expert consensus. Also, in routine care of the patients many clinicians fail to obtain a 1 week follow up US to confirm efficacy of the systemic anticoagulation. They rely on patient symptoms and patients have different thresholds for communicating their symptoms to their physicians which may lead to delayed care and potential loss of efficient endovascular therapeutic window.
This randomized controlled study aims to fill this gap by using CDT and MT as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation trial for one week.
As per the standard of care all patients diagnosed with acute iliofemoral DVT are being seen in IR clinic 1 week after (+/- 3 days) the first notification to DVT team which is covered by IR 24/7, to assess the improvement after initial anticoagulation trial.
During the clinic visit a venous duplex ultrasound imaging is performed to assess the thrombus burden compared to initial presentation. After the US study, clinical evaluation will be performed using Marder Score and Villalta Score systems. Patients who failed to improve after initial anticoagulation treatment will be offered enrollment to the study.
After enrollment, patients will be randomized with 1:1 ratio by a web-based randomization tool.
Control Arm:
Control arm will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed.
Intervention Arm:
Patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms.
Patients' post-procedural Villalta scores and Marder Scores of pre/post-procedure venography and duplex ultrasound will be recorded at discharge.
Crossover To Intervention Arm:
Crossover from control arm to intervention arm will be considered when following conditions occur:
- Clinical and/or imaging deterioration according to Villalta/Marder score systems.
- Symptoms suggesting arterial vascular compromise
- Development of new acute thrombus under anticoagulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After enrollment, patients will be randomized with 1:1 ratio by a web-based randomization tool. Control Arm: Control arm will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed. Intervention Arm: Patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms. Patients' post-procedural Villalta scores and Marder Scores of pre/post-procedure venography and duplex ultrasound will be recorded at discharge.
| Arm | Type | Receives |
|---|---|---|
| Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulation | No intervention | –Patients presenting to emergency department with the following criteria: over 18 years of age, who have diagnosis of acute femoropopliteal acute deep venous thrombus, placed on anticoagulation treatment and failed to resolve the DVT in 1 week (+/- 3 days) follow up Doppler US study. In control arm the treatment will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed. |
| Unresolved Deep Venous Thrombosis Patients managed by interventional therapies. | Experimental | Other: Thrombolysis/ThrombectomyPatients presenting to emergency department with the following criteria: over 18 years of age, who have diagnosis of acute femoropopliteal acute deep venous thrombus, placed on anticoagulation treatment and failed to resolve the DVT in 1 week (+/- 3 days) follow up Doppler US study. In intervention arm, patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus
- Patients eligible for anticoagulation treatment
Key exclusion criteria (22 listed)
- Patients under 18 years of age
- Patients over 75 years of age
- Symptoms starting date of more than 14 days
- Patients who have contraindication for anticoagulation treatment
- Patients who have high bleeding risk (more than 2 of the following risk factors):
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 |
|---|---|---|
| Thrombolysis/ThrombectomyEndovascular interventions will be either catheter directed thrombolysis or mechanical thrombectomy procedures both of which have been cleared by FDA for the treatment of acute DVT. Catheter-directed thrombolysis involves the use of a catheter to deliver thrombolytic agents directly to the site of the clot, effectively dissolving the thrombus. Mechanical thrombectomy, on the other hand, employs specialized devices to physically remove the clot from the vessel. These procedures have been cleared by FDA as they are targeted approaches to safely and effectively restore blood flow and reduce the risk of complications associated with acute DVT. | Other | Unresolved Deep Venous Thrombosis Patients managed by interventional therapies. |
Primary outcome
Efficacy of Endovascular Treatments Clinically
Time frame: 30 days
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Clinically
Time frame: 90 days
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Clinically
Time frame: 180 days
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Clinically
Time frame: 12 months
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Sonographically
Time frame: 30 days
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden. The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Sonographically
Time frame: 90 days
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden. The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Sonographically
Time frame: 180 days
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden. The scores will be compared between arms at the end of the study.
Efficacy of Endovascular Treatments Sonographically
Time frame: 12 months
The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden. The scores will be compared between arms at the end of the study.
1 secondary outcome
Safety of Endovascular Treatments
Time frame: 30 days
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 28 Jan 2026.
- Background: PubMed 21366477Kucher N. Clinical practice. Deep-vein thrombosis of the upper extremities. N Engl J Med. 2011 Mar 3;364(9):861-9. doi: 10.1056/NEJMcp1008740. No abstract available.
- Background: PubMed 20434365Owens CA, Bui JT, Knuttinen MG, Gaba RC, Carrillo TC. Pulmonary embolism from upper extremity deep vein thrombosis and the role of superior vena cava filters: a review of the literature. J Vasc Interv Radiol. 2010 Jun;21(6):779-87. doi: 10.1016/j.jvir.2010.02.021.
- Background: PubMed 26780736Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.
- Background: PubMed 31786086Notten P, Ten Cate-Hoek AJ, Arnoldussen CWKP, Strijkers RHW, de Smet AAEA, Tick LW, van de Poel MHW, Wikkeling ORM, Vleming LJ, Koster A, Jie KG, Jacobs EMG, Ebben HP, Coppens M, Toonder I, Ten Cate H, Wittens CHA. Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial. Lancet Haematol. 2020 Jan;7(1):e40-e49. doi: 10.1016/S2352-3026(19)30209-1. Epub 2019 Nov 27.
- Background: PubMed 30586751Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
- Background: PubMed 26853645Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
- Background: PubMed 34416368Von Ende E, Gayou EL, Chick JFB, Makary MS. Nationwide Trends in Catheter-Directed Therapy Utilization for the Treatment of Lower Extremity Deep Vein Thrombosis in Medicare Beneficiaries. J Vasc Interv Radiol. 2021 Nov;32(11):1576-1582.e1. doi: 10.1016/j.jvir.2021.08.002. Epub 2021 Aug 17.
- Background: PubMed 29211671Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066.
- Background: PubMed 36375763Vedantham S, Desai KR, Weinberg I, Marston W, Winokur R, Patel S, Kolli KP, Azene E, Nelson K. Society of Interventional Radiology Position Statement on the Endovascular Management of Acute Iliofemoral Deep Vein Thrombosis. J Vasc Interv Radiol. 2023 Feb;34(2):284-299.e7. doi: 10.1016/j.jvir.2022.10.038. Epub 2022 Nov 11.
- 501(k) Clearance for Inari Medical, Accessed in June 2024Link provided by the sponsor.
- 501(k) Clearance for Penumbra, Accessed in June 2024Link provided by the sponsor.
- 501(k) Clearance for Innova Vascular, Accessed in June 2024Link provided by the sponsor.
- 501(k) Clearance for Thrombolex, Accessed in June 2024Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be accessible only to the research staff who perform the statistical analysis.
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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.
Bulent Arslan, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thrombolysis/Thrombectomy in people with Deep Venous Thrombosis, run by Rush University Medical Center at 1 site in United States.
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 22 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Emerald Amos, MS (312-947-2518, Emerald_Amos@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Endovascular Treatments Clinically (time frame: 30 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06486181, which also lists 9 linked publications.
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 28 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.