Venous ThrombosisBERNUTIFULNCT01482273
Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis
A study testing CDT+US group and CDT-US group in people with Venous Thrombosis and Postthrombotic Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Venous Thrombosis, Postthrombotic Syndrome
- What is being tested?
- CDT+US group and CDT-US group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Symptomatic proximal DVT involving the iliac and/or common femoral vein, confirmed by Duplex Sonography, Angio-CT, Angio-MRI or Phlebography
- Written informed consent
Who cannot join
- Age less than 18 years or greater than 75 years
- Symptom duration > 14 days for the DVT episode in the index leg (i.e., non-acute DVT).
- In the index leg: established post-thrombotic syndrome (PTS) or previous symptomatic DVT within the last 2 years.
- Limb-threatening circulatory compromise.
- PE with hemodynamic compromise (i.e., hypotension).
- Inability to tolerate catheter procedure due to severe dyspnea or acute systemic illness.
Show all 19Show fewer
- Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR > 2.0 and platelet count < 100 000/mm3)
- Severe renal impairment (estimated GFR < 30 ml/min).
- Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
- History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
- Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control).
- Recently (< 1 mo) had thrombolysis.
- Life expectancy < 6 months or chronic non-ambulatory status.
- Participating in any other investigational drug or device study or previous enrollment in this study
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
Bern, 3010
About this study
Official title: The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.
Read the detailed description
Background
Deep vein thrombosis (DVT) is a public health problem with an annual incidence of 1 per 1000. Besides the acute risk of potentially fatal pulmonary embolism or phlegmasia cerulea dolens, these patients are at increased risk of recurrent venous thromboembolism, and in the long term 20-40% of them develop a post-thrombotic syndrome (PTS). PTS mainly develops in patients with DVT affecting the ilio-femoral veins, adversely affects the quality of life and causes important health care costs to the society. There's evidence that the early removal of the obstructing thrombus reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. Therefore, in addition to standard anticoagulation therapy, the latest international guidelines recommend catheter-directed thrombolysis (CDT) as first-line treatment for patients with ilio-femoral DVT and low bleeding risk. CDT refers to the infusion of thrombolytic drugs directly into the thrombus via a multisidehole catheter which is embedded in the thrombus using imaging guidance. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding Ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis. Although ultrasound-enhanced thrombolysis is now widely used to treat ilio-femoral DVT or high-risk pulmonary embolism, it is currently not known if this technique is superior to standard CDT.
Objective
To determine if the addition of intravascular high-frequency/low-dose ultrasound to standard CDT increases the percentage of clot lysis compared to CDT alone after treatment duration of 15 hours in patients with symptomatic ilio-femoral DVT and low bleeding risk
Methods
Study design: open-label (with blinding of data-analyzing physicians), randomized, controlled, single center clinical trial with a follow-up period of 12 months.
Subjects: total of 20 patients (10 in each study group) of 18-75 years of age with acute, symptomatic, objectively confirmed ilio-femoral DVT and a low bleeding risk.
Intervention: CDT using the EkoSonic Endovascular System with (CDT+US group) or without (CDT-US group) intravascular high-frequency, low-power ultrasound for 15 hours.
- Conditions
- Venous Thrombosis, Postthrombotic Syndrome
- Being tested
- CDT+US group, CDT-US group
- Keywords
- catheter-directed thrombolysis, ilio-femoral deep vein thrombosis, Postthrombotic syndrome, Phlebographic scores, Phlebography, Catheters
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDT+US groupProcedure or surgery
CDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours.
CDT-US groupProcedure or surgery
CDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours.
| Study group | Role | What they receive |
|---|---|---|
| CDT+US group | Active comparator | CDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours. Receives: Procedure: CDT+US group |
| CDT-US group | Active comparator | CDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours. Receives: Procedure: CDT-US group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system
Measured: After 15 hours of CDT
Secondary outcomes (5)
Improvement of the "Venous Registry Index" venographic scoring system
Measured: After 15 hours of CDT
Early symptom relief assessed by standardized limb circumference measurements and validated visual analogue pain scale
Measured: During and after 15 hours of CDT
Treatment related complications
Measured: 30 days
Development of PTS assessed by Villalta scale and Quality of life (CIVIQ)
Measured: After 12 months
Venous valve patency/insufficiency assessed by duplex sonography
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Nils Kucher, MD, Principal investigator, Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of BernTorsten Willenberg, MD, Study director, Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of BernIris Baumgartner, MD, Study director, Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of BernRolf P Engelberger, MD, Study director, Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482273
- Sponsor's protocol ID
- 150/11
- Acronym
- BERNUTIFUL
- Status last verified
- Jul 2015
- First submitted
- 28 Nov 2011
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21.
PubMed 21422387Siddiqi F, Odrljin TM, Fay PJ, Cox C, Francis CW. Binding of tissue-plasminogen activator to fibrin: effect of ultrasound. Blood. 1998 Mar 15;91(6):2019-25.
PubMed 9490686Engelhardt TC, Taylor AJ, Simprini LA, Kucher N. Catheter-directed ultrasound-accelerated thrombolysis for the treatment of acute pulmonary embolism. Thromb Res. 2011 Aug;128(2):149-54. doi: 10.1016/j.thromres.2011.05.014. Epub 2011 Jun 8.
PubMed 21641020Kahn SR, Shrier I, Julian JA, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Lamping DL, Johri M, Ginsberg JS. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008 Nov 18;149(10):698-707. doi: 10.7326/0003-4819-149-10-200811180-00004.
PubMed 19017588Popuri RK, Vedantham S. The role of thrombolysis in the clinical management of deep vein thrombosis. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):479-84. doi: 10.1161/ATVBAHA.110.213413.
PubMed 21325669Grewal NK, Martinez JT, Andrews L, Comerota AJ. Quantity of clot lysed after catheter-directed thrombolysis for iliofemoral deep venous thrombosis correlates with postthrombotic morbidity. J Vasc Surg. 2010 May;51(5):1209-14. doi: 10.1016/j.jvs.2009.12.021. Epub 2010 Mar 27.
PubMed 20347543Grommes J, Strijkers R, Greiner A, Mahnken AH, Wittens CH. Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):526-32. doi: 10.1016/j.ejvs.2010.11.035. Epub 2011 Jan 21.
PubMed 21256773Hull RD, Marder VJ, Mah AF, Biel RK, Brant RF. Quantitative assessment of thrombus burden predicts the outcome of treatment for venous thrombosis: a systematic review. Am J Med. 2005 May;118(5):456-64. doi: 10.1016/j.amjmed.2005.01.025.
PubMed 15866245Sharifi M, Mehdipour M, Bay C, Smith G, Sharifi J. Endovenous therapy for deep venous thrombosis: the TORPEDO trial. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):316-25. doi: 10.1002/ccd.22638.
PubMed 20578224Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829Broderick C, Watson L, Armon MP. Thrombolytic strategies versus standard anticoagulation for acute deep vein thrombosis of the lower limb. Cochrane Database Syst Rev. 2021 Jan 19;1(1):CD002783. doi: 10.1002/14651858.CD002783.pub5.
PubMed 33464575Engelberger RP, Stuck A, Spirk D, Willenberg T, Haine A, Periard D, Baumgartner I, Kucher N. Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis: 1-year follow-up data of a randomized-controlled trial. J Thromb Haemost. 2017 Jul;15(7):1351-1360. doi: 10.1111/jth.13709. Epub 2017 Jun 5.
PubMed 28440041Engelberger RP, Spirk D, Willenberg T, Alatri A, Do DD, Baumgartner I, Kucher N. Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis. Circ Cardiovasc Interv. 2015 Jan;8(1):e002027. doi: 10.1161/CIRCINTERVENTIONS.114.002027.
PubMed 25593121
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BERN Ultrasound-enhanced Thrombolysis for Ilio-Femoral Deep Vein Thrombosis versUs Standard Catheter Directed thromboLysis Trial (BERNUTIFUL-Trial)
- ClinicalTrials.gov ID
- NCT01482273
- Acronym / sponsor ID
- BERNUTIFUL / 150/11
- Conditions
- Venous Thrombosis, Postthrombotic Syndrome
- Keywords
- catheter-directed thrombolysis, ilio-femoral deep vein thrombosis, Postthrombotic syndrome, Phlebographic scores, Phlebography, Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- 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.
Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.
Detailed description
Background
Deep vein thrombosis (DVT) is a public health problem with an annual incidence of 1 per 1000. Besides the acute risk of potentially fatal pulmonary embolism or phlegmasia cerulea dolens, these patients are at increased risk of recurrent venous thromboembolism, and in the long term 20-40% of them develop a post-thrombotic syndrome (PTS). PTS mainly develops in patients with DVT affecting the ilio-femoral veins, adversely affects the quality of life and causes important health care costs to the society. There's evidence that the early removal of the obstructing thrombus reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. Therefore, in addition to standard anticoagulation therapy, the latest international guidelines recommend catheter-directed thrombolysis (CDT) as first-line treatment for patients with ilio-femoral DVT and low bleeding risk. CDT refers to the infusion of thrombolytic drugs directly into the thrombus via a multisidehole catheter which is embedded in the thrombus using imaging guidance. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding Ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis. Although ultrasound-enhanced thrombolysis is now widely used to treat ilio-femoral DVT or high-risk pulmonary embolism, it is currently not known if this technique is superior to standard CDT.
Objective
To determine if the addition of intravascular high-frequency/low-dose ultrasound to standard CDT increases the percentage of clot lysis compared to CDT alone after treatment duration of 15 hours in patients with symptomatic ilio-femoral DVT and low bleeding risk
Methods
Study design: open-label (with blinding of data-analyzing physicians), randomized, controlled, single center clinical trial with a follow-up period of 12 months.
Subjects: total of 20 patients (10 in each study group) of 18-75 years of age with acute, symptomatic, objectively confirmed ilio-femoral DVT and a low bleeding risk.
Intervention: CDT using the EkoSonic Endovascular System with (CDT+US group) or without (CDT-US group) intravascular high-frequency, low-power ultrasound for 15 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDT+US group | Active comparator | Procedure: CDT+US groupCDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours. |
| CDT-US group | Active comparator | Procedure: CDT-US groupCDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic proximal DVT involving the iliac and/or common femoral vein, confirmed by Duplex Sonography, Angio-CT, Angio-MRI or Phlebography
- Written informed consent
Key exclusion criteria (19 listed)
- Age less than 18 years or greater than 75 years
- Symptom duration > 14 days for the DVT episode in the index leg (i.e., non-acute DVT).
- In the index leg: established post-thrombotic syndrome (PTS) or previous symptomatic DVT within the last 2 years.
- Limb-threatening circulatory compromise.
- PE with hemodynamic compromise (i.e., hypotension).
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 |
|---|---|---|
| CDT+US groupCDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours. | Procedure or surgery | CDT+US group |
| CDT-US groupCDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours. | Procedure or surgery | CDT-US group |
Primary outcome
Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system
Time frame: After 15 hours of CDT
5 secondary outcomes
Improvement of the "Venous Registry Index" venographic scoring system
Time frame: After 15 hours of CDT
Early symptom relief assessed by standardized limb circumference measurements and validated visual analogue pain scale
Time frame: During and after 15 hours of CDT
Treatment related complications
Time frame: 30 days
Development of PTS assessed by Villalta scale and Quality of life (CIVIQ)
Time frame: After 12 months
Venous valve patency/insufficiency assessed by duplex sonography
Time frame: After 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Background: PubMed 21422387Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21.
- Background: PubMed 9490686Siddiqi F, Odrljin TM, Fay PJ, Cox C, Francis CW. Binding of tissue-plasminogen activator to fibrin: effect of ultrasound. Blood. 1998 Mar 15;91(6):2019-25.
- Background: PubMed 21641020Engelhardt TC, Taylor AJ, Simprini LA, Kucher N. Catheter-directed ultrasound-accelerated thrombolysis for the treatment of acute pulmonary embolism. Thromb Res. 2011 Aug;128(2):149-54. doi: 10.1016/j.thromres.2011.05.014. Epub 2011 Jun 8.
- Results publication: PubMed 19017588Kahn SR, Shrier I, Julian JA, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Lamping DL, Johri M, Ginsberg JS. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008 Nov 18;149(10):698-707. doi: 10.7326/0003-4819-149-10-200811180-00004.
- Results publication: PubMed 21325669Popuri RK, Vedantham S. The role of thrombolysis in the clinical management of deep vein thrombosis. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):479-84. doi: 10.1161/ATVBAHA.110.213413.
- Results publication: PubMed 20347543Grewal NK, Martinez JT, Andrews L, Comerota AJ. Quantity of clot lysed after catheter-directed thrombolysis for iliofemoral deep venous thrombosis correlates with postthrombotic morbidity. J Vasc Surg. 2010 May;51(5):1209-14. doi: 10.1016/j.jvs.2009.12.021. Epub 2010 Mar 27.
- Results publication: PubMed 21256773Grommes J, Strijkers R, Greiner A, Mahnken AH, Wittens CH. Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis. Eur J Vasc Endovasc Surg. 2011 Apr;41(4):526-32. doi: 10.1016/j.ejvs.2010.11.035. Epub 2011 Jan 21.
- Results publication: PubMed 15866245Hull RD, Marder VJ, Mah AF, Biel RK, Brant RF. Quantitative assessment of thrombus burden predicts the outcome of treatment for venous thrombosis: a systematic review. Am J Med. 2005 May;118(5):456-64. doi: 10.1016/j.amjmed.2005.01.025.
- Results publication: PubMed 20578224Sharifi M, Mehdipour M, Bay C, Smith G, Sharifi J. Endovenous therapy for deep venous thrombosis: the TORPEDO trial. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):316-25. doi: 10.1002/ccd.22638.
- Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
- Derived from this study: PubMed 33464575Broderick C, Watson L, Armon MP. Thrombolytic strategies versus standard anticoagulation for acute deep vein thrombosis of the lower limb. Cochrane Database Syst Rev. 2021 Jan 19;1(1):CD002783. doi: 10.1002/14651858.CD002783.pub5.
- Derived from this study: PubMed 28440041Engelberger RP, Stuck A, Spirk D, Willenberg T, Haine A, Periard D, Baumgartner I, Kucher N. Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis: 1-year follow-up data of a randomized-controlled trial. J Thromb Haemost. 2017 Jul;15(7):1351-1360. doi: 10.1111/jth.13709. Epub 2017 Jun 5.
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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.
Nils Kucher, MD principal investigator
Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
Torsten Willenberg, MD study director
Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
Iris Baumgartner, MD study director
Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDT+US group and CDT-US group in people with Venous Thrombosis and Postthrombotic Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 inclusion and 19 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: finished, as of the sponsor's last update on 17 Jul 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of Total EKOS Thrombus Score, a specifically developed venographic scoring system (time frame: After 15 hours of CDT). 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 NCT01482273, which also lists 13 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 17 Jul 2015.