Acute Deep Venous ThrombosisLEVANTENCT05827120
Endovascular Therapy in Patients With Acute Deep Vein Thrombosis
An observational study of Acute Deep Venous Thrombosis, run by National Institute of Cardiovascular Diseases, Slovakia at 3 sites in Slovakia.
Trial summary
Despite optimal anticoagulation therapy of patients with proximal deep vein thrombosis (DVT), there is still high number of patients suffering from post-thrombotic syndrome (PTS) due to the chronic venous occlusion, suboptimal collateralization, and venous valvular dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Deep Venous Thrombosis
- What is being tested?
- Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis and Local catheter directed thrombolysis alone
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 110 participants
- Where
- 3 sitesSlovakia
- Study dates
- 23 Mar 2021to 24 Feb 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for endovascular treatment of extensive deep venous thrombosis (DVT)
Who may be able to join
- first episode of acute iliofemoral DVT
- duration of symptoms <14 days
- symptomatic patients with no or limited response to initial anticoagulation therapy in terms of symptomatology and signs of recanalization
- low bleeding risk
- good functional capacity and life expectancy
Who cannot join
- - presence of malignity (2 centers out of 3)
- pregnancy
- haemorrhagic diathesis / high risk of bleeding
- negative prognosis of survival
- renal / hepatic failure
- chronic course of DVT
Trial locations and contacts
3 sites in 1 country.
Slovakia3 sites
Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica
Banská Bystrica, 974 01
National Institute of Cardiovascular Diseases, Slovakia
Bratislava, 833 48
East Slovakia Institute of Cardiovascular Diseases in Košice
Košice, 04011
About this study
Official title: Long-term Effect of Different Modes of Endovascular Therapy in Combination With Anticoagulation Treatment in Patients With Acute Extensive Deep Vein Thrombosis (LEVANTE Research)
Despite optimal anticoagulation therapy of patients with proximal deep vein thrombosis (DVT), there is still high number of patients suffering from post-thrombotic syndrome (PTS) due to the chronic venous occlusion, suboptimal collateralization, and venous valvular dysfunction. Last two decades endovascular catheter-based treatment modalities have been tested and used in an attempt to reduce incidence and symptoms of PTS in selected patients.
Especially, patients with extensive iliofemoral DVT have an increased risk of PTS. In an effort to accelerate thrombus dissolution or thrombus extraction, the endovascular removal of acute venous thrombus has been introduced as therapeutic option in patients with extensive iliofemoral DVT.
Read more
Randomized trials of catheter-based strategies for thrombus removal have documented improved vein patency, preserved valves function, and reduced post-thrombotic syndrome.
The aim of our study is to evaluate the safety and efficacy of different types of endovascular methods of treatment followed by anticoagulation therapy in patients with acute extensive DVT. Retrospective multicentre analysis of app 100 patients scheduled for endovascular treatment of extensive DVT. The results of mechanical/pharmacomechanical thrombectomy followed by local catheter directed thrombolysis (CDT), will be compared with CDT alone, or with ultrasound-accelerated thrombolysis. The 24-month incidence of PTS assessed by Villalta scoring system, major bleeding complications, the rate of venous recanalization, recurrence of DVT, and other end-points will be evaluated.
Read the detailed description
Aim: The aim of the study is to evaluate the long-term incidence of PTS in patients treated by different endovascular methods and protocols in combination with anticoagulation medication in patients with acute extensive DVT.
Hypothesis: Mechanical / pharmacomechanical thrombectomy (PMT) following by CDT and further anticoagulation therapy is safe and effective mode of acute DVT treatment with reduction of PTS after 24 months in comparison with historical data and with other modes of endovascular therapy.
Methods: Retrospective multicentre analysis of patients scheduled to interventional endovenous treatment of extensive DVT.
The major end-point:
- The development of PTS during the 24-month follow-up period
The minor end-points:
- The occurrence of major bleeding and live-threatening bleeding episodes
- The development of PTS during the 6-month and 12-month follow-up period
- The rate of venous recanalization after intervention assessed by ultrasound
- The occurrence of pulmonary embolism
- Recurrence of DVT
- Mortality, myocardial infarction, stroke during follow-up
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system.
Patients suitable for endovascular therapy and for enrolment into study:
- first episode of acute iliofemoral DVT
- duration of symptoms <14 days
- symptomatic patients with no or limited response to initial anticoagulation therapy in terms of symptomatology and signs of recanalization
- low bleeding risk
- good functional capacity and life expectancy
Endovascular procedures retrospectively analysed:
- Catheter directed thrombolysis (CDT): dedicated infusion catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is initiated (alteplase 1mg per hour simultaneously with unfractionated heparine (UFH) in anticoagulation dosage); activated partial thromboplastin time (APTT), fibrinogen (Fbg), and blood count must be controlled;
- Mechanical thrombectomy: mechanical aspiration of fresh thrombus; mostly followed by CDT;
- Pharmacomechanical thrombectomy (PMT): combination of some form of mechanical disruption of the thrombus in conjunction with chemical lysis. There is evidence that PMT quickens thrombolysis compared with CDT alone. Dedicated devices combining chemical thrombolysis via power-pulse fluid plus plasminogen activator thrombus penetration, with rheolytic fluid-based disruption of thrombus and catheter-based aspiration thrombectomy.
- Ultrasound-accelerated thrombolysis combines chemical CDT with low-power high-frequency ultrasound application to the proprietary infusion catheter/wire combination, with the ultrasonic vibration purported to hasten thrombus disruption; the addition of ultrasound during lytic infusion increases the surface area of the fibrin, thereby permitting more efficient binding of the plasminogen activator to the fibrin-bound plasminogen
- Stenting of residual thrombotic lesions, and stenting of common iliac vein compression in the presence of May-Thurner syndrome;
Peri-procedure and post-procedure care retrospectively analysed:
- continuous in-hospital monitoring to minimize CDT-related complications;
- APTT, Fbg concentration, and blood count are monitored;
- Anticoagulation after endovascular procedure as standard regimen, if no contraindications, mostly during the 6-month time period; longer anticoagulation regimen is at discretion of treated centre and physician;
- after venous stenting may be consider clopidogrel along with anticoagulation therapy for 1 month (not proven); Ultrasound evaluation during follow-up (data from documentation)
- recanalization - no residual thrombosis
- recanalization >50%
- recanalization <50%
- minimal US signs of recanalization/no recanalization Post-thrombotic syndrome: clinical evaluation and/or Villalta score
- No PTS: Villalta <5 points
- Mild: 5-9 points
- Moderate: 10-14 points
- Severe PTS: ≥15 points/venous ulcer
- Conditions
- Acute Deep Venous Thrombosis
- Being tested
- Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis, Local catheter directed thrombolysis alone
- Keywords
- deep venous thrombosis, endovascular thrombectomy, anticoagulation
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysisDevice
- Catheter directed thrombolysis (CDT): dedicated thrombolytic catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is applied - alteplase 1mg/hour plus unfractionated heparine in anticoagulation dosage;
- Mechanical thrombectomy: mechanical aspiration of fresh thrombus;
- Pharmacomechanical thrombectomy (PMT): combination of mechanical disruption of the thrombus, and its aspiration, with simultaneous application of alteplase via dedicated catheter - instilation of acute/subacute thrombus with its subsequent aspiration;
Local catheter directed thrombolysis aloneDevice
- Catheter directed thrombolysis (CDT): dedicated thrombolytic catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is applied - alteplase 1mg/hour plus unfractionated heparine in anticoagulation dosage;
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy plus local thrombolysis group | Thrombectomy plus local thrombolysis group - patients treated by mechanical thrombectomy mostly followed by catheter directed thrombolysis (CDT), or by pharmaco-mechanical thrombectomy (PMT) - combination of some form of mechanical disruption of the thrombus in conjunction with chemical lysis. Thrombolysis by alteplase 1mg/hour. Procedure followed by anticoagulation therapy. Receives: Device: Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis | |
| Local catheter directed thrombolysis alone group | Local catheter directed thrombolysis alone group - patients treated by dedicated catheter for local thrombolysis with side holes placed across the acute thrombus - continuous infusion of alteplase 1mg per hour simultaneously with unfractionated heparine in anticoagulation dosage. Without mechanical or pharmaco-mechanical thrombectomy. Procedure followed by anticoagulation therapy. Receives: Device: Local catheter directed thrombolysis alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-thrombotic syndrome
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system (0-33), higher scores mean a worse outcome.
Measured: 24-month follow-up period
Secondary outcomes (6)
The occurrence of major bleeding and live-threatening bleeding episodes
clinical and laboratory evaluation of bleeding
Measured: periprocedural, in-hospital (up to day 7), 24 months
The development of PTS during the 6-month and 12-month follow-up period
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system (0-33), higher scores mean a worse outcome.
Measured: 6-month and 12-month follow-up period
The rate of venous recanalization after intervention
assessed by ultrasound
Measured: early - in-hospital (up to day 7), 6-month
The occurrence of pulmonary embolism
clinical evaluation
Measured: early - in-hospital (up to day 7), 12-month, 24-month follow-up
Recurrence of DVT
clinical and ultrasound evaluation
Measured: 12-month, 24-month follow-up
Mortality, MI, stroke during follow-up
history assessment
Measured: In-hospital (up to day 7), 12-month, 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start23 Mar 2021
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute Deep Venous ThrombosisStudies 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
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Slovakia
- Sponsor type
- University, hospital or other
- Collaborators
- East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia, Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica, Slovakia
- Responsible party
- Principal investigator, Juraj Maďarič, MD, National Institute of Cardiovascular Diseases, Slovakia
- Investigators
- Juraj Maďarič, assoc. prof, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827120
- Sponsor's protocol ID
- 65176743 / LEVA002NUSCH
- Acronym
- LEVANTE
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
PubMed 25246013Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772.
PubMed 26438686Comerota AJ, Grewal N, Martinez JT, Chen JT, Disalle R, Andrews L, Sepanski D, Assi Z. Postthrombotic morbidity correlates with residual thrombus following catheter-directed thrombolysis for iliofemoral deep vein thrombosis. J Vasc Surg. 2012 Mar;55(3):768-73. doi: 10.1016/j.jvs.2011.10.032. Epub 2012 Jan 24.
PubMed 22277690Tick LW, Doggen CJ, Rosendaal FR, Faber WR, Bousema MT, Mackaay AJ, VAN Balen P, Kramer MH. Predictors of the post-thrombotic syndrome with non-invasive venous examinations in patients 6 weeks after a first episode of deep vein thrombosis. J Thromb Haemost. 2010 Dec;8(12):2685-92. doi: 10.1111/j.1538-7836.2010.04065.x.
PubMed 20860679Delis KT, Bountouroglou D, Mansfield AO. Venous claudication in iliofemoral thrombosis: long-term effects on venous hemodynamics, clinical status, and quality of life. Ann Surg. 2004 Jan;239(1):118-26. doi: 10.1097/01.sla.0000103067.10695.74.
PubMed 14685109Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.
PubMed 26867832Jaff 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 21422387Meissner MH, Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Lohr JM, McLafferty RB, Murad MH, Padberg F, Pappas P, Raffetto JD, Wakefield TW; Society for Vascular Surgery; American Venous Forum. Early thrombus removal strategies for acute deep venous thrombosis: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2012 May;55(5):1449-62. doi: 10.1016/j.jvs.2011.12.081. Epub 2012 Apr 1.
PubMed 22469503Sharifi M, Bay C, Mehdipour M, Sharifi J; TORPEDO Investigators. Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion (TORPEDO) trial: midterm results. J Endovasc Ther. 2012 Apr;19(2):273-80. doi: 10.1583/11-3674MR.1.
PubMed 22545895Kahn SR, Julian JA, Kearon C, Gu CS, Cohen DJ, Magnuson EA, Comerota AJ, Goldhaber SZ, Jaff MR, Razavi MK, Kindzelski AL, Schneider JR, Kim P, Chaer R, Sista AK, McLafferty RB, Kaufman JA, Wible BC, Blinder M, Vedantham S; ATTRACT Trial Investigators. Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020 Jan;8(1):8-23.e18. doi: 10.1016/j.jvsv.2019.03.023.
PubMed 31843251Comerota 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 30586751Lu T, Loh TM, El-Sayed HF, Davies MG. Single-center retrospective review of ultrasound-accelerated versus traditional catheter-directed thrombolysis for acute lower extremity deep venous thrombosis. Vascular. 2017 Oct;25(5):525-532. doi: 10.1177/1708538117702061. Epub 2017 Apr 3.
PubMed 28372484Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.
PubMed 19222476Haig 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 26853645Vedantham 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 29211671
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Different Modes of Endovascular Therapy in Combination With Anticoagulation Treatment in Patients With Acute Extensive Deep Vein Thrombosis (LEVANTE Research)
- ClinicalTrials.gov ID
- NCT05827120
- Acronym / sponsor ID
- LEVANTE / 65176743 / LEVA002NUSCH
- Conditions
- Acute Deep Venous Thrombosis
- Keywords
- deep venous thrombosis, endovascular thrombectomy, anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, SlovakiaUniversity, hospital or other
- Collaborators
- East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia, Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica, Slovakia
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 24 Apr 2023 (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.
Despite optimal anticoagulation therapy of patients with proximal deep vein thrombosis (DVT), there is still high number of patients suffering from post-thrombotic syndrome (PTS) due to the chronic venous occlusion, suboptimal collateralization, and venous valvular dysfunction. Last two decades endovascular catheter-based treatment modalities have been tested and used in an attempt to reduce incidence and symptoms of PTS in selected patients.
Especially, patients with extensive iliofemoral DVT have an increased risk of PTS. In an effort to accelerate thrombus dissolution or thrombus extraction, the endovascular removal of acute venous thrombus has been introduced as therapeutic option in patients with extensive iliofemoral DVT.
Randomized trials of catheter-based strategies for thrombus removal have documented improved vein patency, preserved valves function, and reduced post-thrombotic syndrome.
The aim of our study is to evaluate the safety and efficacy of different types of endovascular methods of treatment followed by anticoagulation therapy in patients with acute extensive DVT. Retrospective multicentre analysis of app 100 patients scheduled for endovascular treatment of extensive DVT. The results of mechanical/pharmacomechanical thrombectomy followed by local catheter directed thrombolysis (CDT), will be compared with CDT alone, or with ultrasound-accelerated thrombolysis. The 24-month incidence of PTS assessed by Villalta scoring system, major bleeding complications, the rate of venous recanalization, recurrence of DVT, and other end-points will be evaluated.
Detailed description
Aim: The aim of the study is to evaluate the long-term incidence of PTS in patients treated by different endovascular methods and protocols in combination with anticoagulation medication in patients with acute extensive DVT.
Hypothesis: Mechanical / pharmacomechanical thrombectomy (PMT) following by CDT and further anticoagulation therapy is safe and effective mode of acute DVT treatment with reduction of PTS after 24 months in comparison with historical data and with other modes of endovascular therapy.
Methods: Retrospective multicentre analysis of patients scheduled to interventional endovenous treatment of extensive DVT.
The major end-point:
- The development of PTS during the 24-month follow-up period
The minor end-points:
- The occurrence of major bleeding and live-threatening bleeding episodes
- The development of PTS during the 6-month and 12-month follow-up period
- The rate of venous recanalization after intervention assessed by ultrasound
- The occurrence of pulmonary embolism
- Recurrence of DVT
- Mortality, myocardial infarction, stroke during follow-up
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system.
Patients suitable for endovascular therapy and for enrolment into study:
- first episode of acute iliofemoral DVT
- duration of symptoms <14 days
- symptomatic patients with no or limited response to initial anticoagulation therapy in terms of symptomatology and signs of recanalization
- low bleeding risk
- good functional capacity and life expectancy
Endovascular procedures retrospectively analysed:
- Catheter directed thrombolysis (CDT): dedicated infusion catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is initiated (alteplase 1mg per hour simultaneously with unfractionated heparine (UFH) in anticoagulation dosage); activated partial thromboplastin time (APTT), fibrinogen (Fbg), and blood count must be controlled;
- Mechanical thrombectomy: mechanical aspiration of fresh thrombus; mostly followed by CDT;
- Pharmacomechanical thrombectomy (PMT): combination of some form of mechanical disruption of the thrombus in conjunction with chemical lysis. There is evidence that PMT quickens thrombolysis compared with CDT alone. Dedicated devices combining chemical thrombolysis via power-pulse fluid plus plasminogen activator thrombus penetration, with rheolytic fluid-based disruption of thrombus and catheter-based aspiration thrombectomy.
- Ultrasound-accelerated thrombolysis combines chemical CDT with low-power high-frequency ultrasound application to the proprietary infusion catheter/wire combination, with the ultrasonic vibration purported to hasten thrombus disruption; the addition of ultrasound during lytic infusion increases the surface area of the fibrin, thereby permitting more efficient binding of the plasminogen activator to the fibrin-bound plasminogen
- Stenting of residual thrombotic lesions, and stenting of common iliac vein compression in the presence of May-Thurner syndrome;
Peri-procedure and post-procedure care retrospectively analysed:
- continuous in-hospital monitoring to minimize CDT-related complications;
- APTT, Fbg concentration, and blood count are monitored;
- Anticoagulation after endovascular procedure as standard regimen, if no contraindications, mostly during the 6-month time period; longer anticoagulation regimen is at discretion of treated centre and physician;
- after venous stenting may be consider clopidogrel along with anticoagulation therapy for 1 month (not proven); Ultrasound evaluation during follow-up (data from documentation)
- recanalization - no residual thrombosis
- recanalization >50%
- recanalization <50%
- minimal US signs of recanalization/no recanalization Post-thrombotic syndrome: clinical evaluation and/or Villalta score
- No PTS: Villalta <5 points
- Mild: 5-9 points
- Moderate: 10-14 points
- Severe PTS: ≥15 points/venous ulcer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy plus local thrombolysis group | – | Device: Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysisThrombectomy plus local thrombolysis group - patients treated by mechanical thrombectomy mostly followed by catheter directed thrombolysis (CDT), or by pharmaco-mechanical thrombectomy (PMT) - combination of some form of mechanical disruption of the thrombus in conjunction with chemical lysis. Thrombolysis by alteplase 1mg/hour. Procedure followed by anticoagulation therapy. |
| Local catheter directed thrombolysis alone group | – | Device: Local catheter directed thrombolysis aloneLocal catheter directed thrombolysis alone group - patients treated by dedicated catheter for local thrombolysis with side holes placed across the acute thrombus - continuous infusion of alteplase 1mg per hour simultaneously with unfractionated heparine in anticoagulation dosage. Without mechanical or pharmaco-mechanical thrombectomy. Procedure followed by anticoagulation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for endovascular treatment of extensive deep venous thrombosis (DVT)
Key inclusion criteria (5 listed)
- first episode of acute iliofemoral DVT
- duration of symptoms <14 days
- symptomatic patients with no or limited response to initial anticoagulation therapy in terms of symptomatology and signs of recanalization
- low bleeding risk
- good functional capacity and life expectancy
Key exclusion criteria (6 listed)
- - presence of malignity (2 centers out of 3)
- pregnancy
- haemorrhagic diathesis / high risk of bleeding
- negative prognosis of survival
- renal / hepatic failure
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 |
|---|---|---|
| Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis* Catheter directed thrombolysis (CDT): dedicated thrombolytic catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is applied - alteplase 1mg/hour plus unfractionated heparine in anticoagulation dosage; * Mechanical thrombectomy: mechanical aspiration of fresh thrombus; * Pharmacomechanical thrombectomy (PMT): combination of mechanical disruption of the thrombus, and its aspiration, with simultaneous application of alteplase via dedicated catheter - instilation of acute/subacute thrombus with its subsequent aspiration; | Device | Thrombectomy plus local thrombolysis group |
| Local catheter directed thrombolysis alone- Catheter directed thrombolysis (CDT): dedicated thrombolytic catheter with side holes is placed across the acute thrombus, and slow, continuous infusion (through the catheter, or both through the catheter and sheath) of a chemical thrombolysis agent is applied - alteplase 1mg/hour plus unfractionated heparine in anticoagulation dosage; | Device | Local catheter directed thrombolysis alone group |
Primary outcome
Post-thrombotic syndrome
Time frame: 24-month follow-up period
The occurrence of PTS will be assessed by clinical evaluation and by Villalta scoring system (0-33), higher scores mean a worse outcome.
6 secondary outcomes
The occurrence of major bleeding and live-threatening bleeding episodes
Time frame: periprocedural, in-hospital (up to day 7), 24 months
The development of PTS during the 6-month and 12-month follow-up period
Time frame: 6-month and 12-month follow-up period
The rate of venous recanalization after intervention
Time frame: early - in-hospital (up to day 7), 6-month
The occurrence of pulmonary embolism
Time frame: early - in-hospital (up to day 7), 12-month, 24-month follow-up
Recurrence of DVT
Time frame: 12-month, 24-month follow-up
Mortality, MI, stroke during follow-up
Time frame: In-hospital (up to day 7), 12-month, 24-month follow-up
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 25 Apr 2023.
- Background: PubMed 25246013Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available.
- Background: PubMed 26438686Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772.
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- Individual participant dataSharing planned: Undecided
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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.
Juraj Maďarič, assoc. prof principal investigator
National Institute of Cardiovascular Diseases
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Deep Venous Thrombosis, run by National Institute of Cardiovascular Diseases, Slovakia at 3 sites in Slovakia.
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 5 inclusion and 6 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovakia. 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?
Post-thrombotic syndrome (time frame: 24-month follow-up period). 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 NCT05827120, which also lists 16 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 25 Apr 2023.