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DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. (NL28394)

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ClinicalTrials.gov Identifier: NCT00970619
Recruitment Status : Recruiting
First Posted : September 2, 2009
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post thrombotic morbidity. The presence of both obstruction and reflux significantly increases the chances for development of post-thrombotic syndrome (PTS). Early thrombolysis may reduce the incidence of PTS as compared to treatment with conventional anticoagulant medication alone. Improvement of the health related quality of life (HRQOL) has been reported after surgical clot removal. The investigators hypothesize that such improvements could also be reached after catheter directed thrombolysis.

Objective: To assess whether catheter directed thrombolytic therapy for the treatment of IFDVT can safely and effectively reduce post thrombotic morbidity after one year. The secondary objective is to study whether catheter directed thrombolytic intervention has a positive effect on the quality of life of patients with IFDVT and to assess late PTS.

Study design: prospective, non blinded, randomized, controlled, multicenter, intervention study

Study population: The study population includes all consecutive patients with IFDVT presenting at the emergency or outpatient departments of the participating centres. The thrombus should not be older than 14 days at randomization.

Intervention: After randomization patients will be allocated to either conservative anticoagulant treatment or to catheter directed thrombolysis combined with conservative anticoagulant treatment.

Main study parameters/endpoints: The primary efficacy outcome is the incidence of PTS at one year; a decline in PTS incidence from 25% to 8% is anticipated. The secondary outcome is the Health related Quality of life and late PTS during follow-up. The principal safety outcome is major bleeding during anticoagulant therapy. Bleeding as well as events of recurrent thrombosis will be monitored. The patency of the venous system of the affected lower limb will be assessed as well as the percentage of clot lysis, after thrombolytic intervention. Additionally, measurements of markers of coagulation and inflammation will be performed during follow-up.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For patients who are randomized to the intervention arm of the study a hospital stay for 24-36 hour is mandatory during catheter directed thrombolysis. All patients will undergo additional imaging by MRA-vasovist and air phletysmography (APG) at baseline and after 12 months. Clinical follow-up visits will be matching usual care at 3, 6, 12 months; blood will be taken at these visits. Health-related quality of life (HRQOL) questionnaires will be filled out by all patients at baseline, 3, 6 and 12 months after the event; and once a year during the entire study duration. Further treatment will be in accordance with current guidelines for antithrombotic treatment. There may be an enhanced risk of bleeding in the thrombolysis group. The expected benefit is reduction of PTS from 25% to 8%, together with an improved quality of life.


Condition or disease Intervention/treatment Phase
Acute Thrombosis of Deep Veins of Proximal Lower Extremity Device: Ekos endowave system thrombolysis Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Accelerated Catheter-directed Thrombolysis for Primary Iliofemoral Deep Vein Thrombosis (IFDVT) Compared to Non-invasive Conventional Anticoagulant Therapy Alone: a Dutch Randomized Controlled Multicenter Clinical Trial.
Study Start Date : May 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Conventional anticoagulation therapy
Conservative treatment consists of an initial treatment with therapeutic doses of LMWH in combination with vitamin K-antagonists, followed by treatment with vitamin K-antagonist alone (after completing LMWH treatment of at least 5-7 days and after an INR above 2 has been reached on two consecutive measurements). Or alternatively the new direct activated factor X inhibitors can be used as anticoagulation therapy. Anticoagulant treatment will be installed according to national and international guidelines (ACCP 2008 [23], CBO 2008 [24]) tailored based on the character of the event (6 months of therapy for idiopathic DVT and 3 months for provoked DVT).
Experimental: Ekos Endowave system thrombolysis
Catheter directed thrombolysis will be performed with an Ekos Endowave ® system (EKOS Corporation, Bothell, WA). The system uses a standard guide wire to position the Intelligent Drug Delivery Catheter across the length of the target clot. The guide wire is introduced through the popliteal vein. Along the guide wire the catheter is positioned. The location of the dispersion catheter is controlled and if necessary adjusted by X-ray. The guide wire is then pulled out and replaced with the Microsonic core (a miniscule high frequency (2MHz) ultrasound transducer). The system automatically monitors and controls the microsonic energy delivery. This system does not fragment the thrombus but only gives a structural change by which a better penetration of the thrombolytic agent is achieved.
Device: Ekos endowave system thrombolysis
Catheter directed thrombolysis will be performed with an Ekos Endowave ® system (EKOS Corporation, Bothell, WA). The system uses a standard guide wire to position the Intelligent Drug Delivery Catheter across the length of the target clot. The guide wire is introduced through the popliteal vein. Along the guide wire the catheter is positioned. The location of the dispersion catheter is controlled and if necessary adjusted by X-ray. The guide wire is then pulled out and replaced with the Microsonic core (a miniscule high frequency (2MHz) ultrasound transducer). The system automatically monitors and controls the microsonic energy delivery. This system does not fragment the thrombus but only gives a structural change by which a better penetration of the thrombolytic agent is achieved.
Other Name: Ekos endowave ® system



Primary Outcome Measures :
  1. Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. The Health Related Quality of Life (HRQOL) [ Time Frame: 5 years ]
  2. PTS during follow-up [ Time Frame: 5 years ]
  3. Recurrent venous thrombo-embolisms (VTE): DVT/PE during follow-up [ Time Frame: 5 years ]
  4. Clot lysis, patency and valve function [ Time Frame: 5 years ]
  5. Measurements of markers of coagulation and inflammation [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Objectively documented IFDVT
  • Acute stage IFDVT, complaints less than 14 days
  • Life expectancy longer than 6 months
  • First thrombus in the affected limb

Exclusion Criteria:

  • History of GI bleeding within 1 year
  • History of CVA/CNS disease within 1 year
  • Severe hypertension (>180/100 mmHg)
  • Active malignancy
  • Major surgery within 6 weeks
  • Previous thrombosis of the affected limb (secondary thrombosis)
  • Varicosities/venous insufficiency CEAP classification C3 or higher
  • Pregnancy
  • Immobility (wheelchair dependent)
  • ALAT > 3 times normal range
  • eGFR < 30 mL/min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970619


Contacts
Contact: margriet rennenberg-stokbroek +31653129126 margriet.stokbroek@mumc.nl
Contact: Hugo ten Cate, MD, PhD +31433884262 h.ten.cate@mumc.nl

Locations
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: margriet rennenberg-stokbroek    +31653129126    cava@maastrichtuniversity.nl   
Contact: Arina ten Cate, MD, PhD    +31433871243    arina.tencate@maastrichtuniversity.nl   
Haga Ziekenhuis Recruiting
's-Gravenhage, Netherlands
Contact: L Vleming, MD, PhD         
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands
Contact: M Coppens, MD, PhD         
VuMC Recruiting
Amsterdam, Netherlands
Contact: H Ebben, MD, PhD         
Nij Smellinghe Recruiting
Drachten, Netherlands
Contact: O Wikkeling, MD, PhD         
Catharina Ziekenhuis Eindhoven Terminated
Eindhoven, Netherlands
MMC Eindhoven Recruiting
Eindhoven, Netherlands
Contact: L Tick, PhD         
St Anna Ziekenhuis Recruiting
Geldrop, Netherlands
Contact: A Stork, MD, PhD         
Atrium MC Heerlen Recruiting
Heerlen, Netherlands
Contact: G. Mostard, MD         
Elkerliek Ziekenhuis Recruiting
Helmond, Netherlands
Contact: E Jacobs, MD, PhD         
St Antonius Terminated
Nieuwegein, Netherlands
Laurentius Roermond Recruiting
Roermond, Netherlands
Contact: M van de Poel, MD         
Maasstad ziekenhuis Recruiting
Rotterdam, Netherlands
Contact: A de Smet, MD, PhD         
VieCuri Recruiting
Venlo, Netherlands
Contact: A Koster, MD, PhD         
Sint Jans Gasthuis Recruiting
Weert, Netherlands
Contact: A Gaijic, MD, PhD         
Isala klinieken Recruiting
Zwolle, Netherlands
Contact: M Pierie, MD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Hugo ten Cate, MD, PhD Maastricht University Medical Centre

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00970619     History of Changes
Other Study ID Numbers: MEC 09-2-093
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: June 2017

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anticoagulants