Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486181
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-29
Brief Title:
Second Line Endovascular Treatment in Acute DVT
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
A Randomized Controlled Trial for Second Line Treatment of Acute DVT With Endovascular Interventional Treatments
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 11 ratio Researchers will compare follow-up Villalta and Marder scores between groups to see whether endovascular interventions are safe and efficient
- 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 11 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 100000 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 854 at one-year post-diagnosis declining to 726 at the five-year mark in epidemiologic studies 3 A large prospective cohort study showed that patients with acute iliofemoral DVT have 24 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 056 However the ATTRACT trial demonstrated significant improvement in early symptoms within 30 days in CDT arm p 0001 Moreover CDT treatment was shown to reduce the occurrence of moderate or severe PTS 18 vs 28 p 002 with reducing severity of PTS as well mean differences 16 in Villalta Scores between groups p 0001
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 247 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 11 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 operators preference availability of device and the patients bleeding risk The endovascular procedure will be scheduled within 15 days of the initial symptoms
Patients post-procedural Villalta scores and Marder Scores of prepost-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 andor imaging deterioration according to VillaltaMarder score systems
Symptoms suggesting arterial vascular compromise
Development of new acute thrombus under anticoagulation
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 056 However the ATTRACT trial demonstrated significant improvement in early symptoms within 30 days in CDT arm p 0001 Moreover CDT treatment was shown to reduce the occurrence of moderate or severe PTS 18 vs 28 p 002 with reducing severity of PTS as well mean differences 16 in Villalta Scores between groups p 0001
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 247 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 11 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 operators preference availability of device and the patients bleeding risk The endovascular procedure will be scheduled within 15 days of the initial symptoms
Patients post-procedural Villalta scores and Marder Scores of prepost-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 andor imaging deterioration according to VillaltaMarder score systems
Symptoms suggesting arterial vascular compromise
Development of new acute thrombus under anticoagulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None