Endovascular Therapy in Patients With Acute Deep Vein Thrombosis
NCT ID: NCT05827120
Last Updated: 2023-04-25
Study Results
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Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2021-03-23
2023-02-24
Brief Summary
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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.
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Detailed Description
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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:
1\. The development of PTS during the 24-month follow-up period
The minor end-points:
1. The occurrence of major bleeding and live-threatening bleeding episodes
2. The development of PTS during the 6-month and 12-month follow-up period
3. The rate of venous recanalization after intervention assessed by ultrasound
4. The occurrence of pulmonary embolism
5. Recurrence of DVT
6. 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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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;
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.
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;
Interventions
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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;
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;
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* pregnancy
* haemorrhagic diathesis / high risk of bleeding
* negative prognosis of survival
* renal / hepatic failure
* chronic course of DVT
18 Years
ALL
No
Sponsors
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East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia
UNKNOWN
Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica, Slovakia
UNKNOWN
National Institute of Cardiovascular Diseases, Slovakia
OTHER
Responsible Party
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Juraj Maďarič, MD
assoc. prof. Juraj Maďarič, PhD., MPH, Department of Cardiology and Angiology - head of the unit
Principal Investigators
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Juraj Maďarič, assoc. prof
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiovascular Diseases
Locations
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Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica
Banská Bystrica, , Slovakia
National Institute of Cardiovascular Diseases, Slovakia
Bratislava, , Slovakia
East Slovakia Institute of Cardiovascular Diseases in Košice
Košice, , Slovakia
Countries
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References
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Comerota 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.
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Vedantham 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.
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Other Identifiers
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65176743 / LEVA002NUSCH
Identifier Type: -
Identifier Source: org_study_id
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