Endovascular Therapy in Patients With Acute Deep Vein Thrombosis

NCT05827120 | Completed

• 1 other identifier: 65176743 / LEVA002NUSCH
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Acute Deep Venous Thrombosis

Keywords

deep venous thrombosis; endovascular thrombectomy; anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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.

  24-month follow-up period

Secondary Outcomes (6)

• The occurrence of major bleeding and live-threatening bleeding episodes

  periprocedural, in-hospital (up to day 7), 24 months

• The development of PTS during the 6-month and 12-month follow-up period

  6-month and 12-month follow-up period

• The rate of venous recanalization after intervention

  early - in-hospital (up to day 7), 6-month

• The occurrence of pulmonary embolism

  early - in-hospital (up to day 7), 12-month, 24-month follow-up

• Recurrence of DVT

  12-month, 24-month follow-up

Study Arms (2)

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.

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.

Device: Local catheter directed thrombolysis alone

Interventions

Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis DEVICE

* 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;

Thrombectomy plus local thrombolysis group

Local catheter directed thrombolysis alone DEVICE

\- 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;

Local catheter directed thrombolysis alone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for endovascular treatment of extensive deep venous thrombosis (DVT)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Slovakia: lead
• East Slovakia Institute of Cardiovascular Diseases in Košice, Slovakia: collaborator
• Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica, Slovakia: collaborator

Study Sites (3)

Central Slovakia Institute of Cardiovascular Diseases in Banská Bystrica

Banská Bystrica, 974 01, Slovakia

Location

National Institute of Cardiovascular Diseases, Slovakia

Bratislava, 833 48, Slovakia

Location

East Slovakia Institute of Cardiovascular Diseases in Košice

Košice, 04011, Slovakia

Location

Related Publications (16)

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• Meissner 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.

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  PMID: 22545895 BACKGROUND

• Kahn 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.

  PMID: 31843251 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

• Lu 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.

  PMID: 28372484 BACKGROUND

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  PMID: 26853645 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.

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• Leung DA, Blitz LR, Nelson T, Amin A, Soukas PA, Nanjundappa A, Garcia MJ, Lookstein R, Simoni EJ. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. J Endovasc Ther. 2015 Aug;22(4):546-57. doi: 10.1177/1526602815592849. Epub 2015 Jun 24.

  PMID: 26109628 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juraj Maďarič, assoc. prof

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. Juraj Maďarič, PhD., MPH, Department of Cardiology and Angiology - head of the unit

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 24, 2023
• Study Start: March 23, 2021
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

SL (3)