Second Line Endovascular Treatment in Acute DVT

NCT06486181 | Not Yet Recruiting Phase 4 FDA Device

• 1 other identifier: 24020105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 1:1 ratio. Researchers will compare follow-up Villalta and Marder scores between groups to see whether endovascular interventions are safe and efficient.

Conditions

Deep Venous Thrombosis

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  12 months

Secondary Outcomes (1)

• Safety of Endovascular Treatments

  30 days

Study Arms (2)

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.

Other: Thrombolysis/Thrombectomy

Interventions

Thrombolysis/Thrombectomy OTHER

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.

Unresolved Deep Venous Thrombosis Patients managed by interventional therapies.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus
• Patients eligible for anticoagulation treatment

You may not qualify if:

• 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
• Previous bleeding
• Cancer
• Metastatic cancer
• Renal failure
• Liver failure
• Thrombocytopenia
• Previous stroke
• Diabetes
• Anemia

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (9)

• 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.

  PMID: 21366477 BACKGROUND

• Owens 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.

  PMID: 20434365 BACKGROUND

• Heit 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.

  PMID: 26780736 BACKGROUND

• Notten 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.

  PMID: 31786086 BACKGROUND

• Comerota 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.

  PMID: 30586751 BACKGROUND

• Haig 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.

  PMID: 26853645 BACKGROUND

• Von 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.

  PMID: 34416368 BACKGROUND

• 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.

  PMID: 29211671 BACKGROUND

• Vedantham 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.

  PMID: 36375763 BACKGROUND

Related Links

• 501(k) Clearance for Inari Medical, Accessed in June 2024
• 501(k) Clearance for Penumbra, Accessed in June 2024
• 501(k) Clearance for Innova Vascular, Accessed in June 2024
• 501(k) Clearance for Thrombolex, Accessed in June 2024

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Fibrinolytic Agents; Thrombectomy

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bulent Arslan, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emerald Amos, MS

CONTACT

312-947-2518; Emerald_Amos@rush.edu

Okan Ince, MS

CONTACT

312-947-2508; Okan_Ince@rush.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: July 3, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)