Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis (CLEAR-DVT)
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|ClinicalTrials.gov Identifier: NCT03901872|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : August 2, 2019
|Condition or disease||Intervention/treatment|
|Thrombolysis Deep Vein Thrombosis||Device: Contemporary endovascular venous intervention by Zelante pharmacomechanical thrombolysis|
A single arm cohort will serve as a proof of principle study, and be the foundation for a larger subsequent prospective, Randomised Clinical Trial (RCT). The aim of this initial single arm cohort is to both validate that contemporary catheter directed therapy performed by experienced operators has significant efficacy and safety at 10 days, 30 days, 6 months, 12 months, and 2 years (details below). If a strong signal of efficacy and safety is found in the initial single arm cohort at 30 days and 6 months, this will provide objective evidence to move forward with a larger multicentre, prospective, RCT.
If the results of the initial single arm proof of principle cohort do not show efficacy, or there is a safety issue, a larger prospective, RCT will not be performed.
|Study Type :||Observational|
|Estimated Enrollment :||65 participants|
|Official Title:||Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis A Prospective, Multicentre Cohort Trial A Physician Initiated Research Study Request|
|Actual Study Start Date :||March 29, 2019|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
Acute Iliofemoral DVT
Suitable patients would be invited to take part in this trial as part of standard of care.
Device: Contemporary endovascular venous intervention by Zelante pharmacomechanical thrombolysis
All patients will undergo ultrasound guided micro puncture venous access of the enrolled ipsilateral lower extremity popliteal vein followed by a diagnostic venogram to define thrombus burden and anatomic extent of DVT. Prior to and every 30 minutes during the endovascular procedure, an activated clotting time (ACT) will be obtained. Intravenous unfractionated heparin will be administered to keep the ACT between 250 - 300. A Zelante catheter will be utilised to perform pharmacomechanical thrombolysis of the enrolled lower extremity. If there is involvement of the popliteal and/or femoral vein, pharmacomechanical thrombolysis should also be performed of these veins. Venous stenting may be implemented to address areas of residual venous stenosis or outflow obstruction following pharmacomechanical thrombolysis. Stent placement in the common iliac, external iliac, and common femoral vein are routinely done to address inflow or outflow issues after pharmacomechanical thrombolysis.
- Rate of Post thrombotic Syndrome at 2 years [ Time Frame: 2 years ]
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): NCT03901872
|Contact: Audrey Hau||02071887188 ext firstname.lastname@example.org|
|Contact: Stephen Black||02071887188 ext email@example.com|
|Guy's & St Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE1 7EH|
|Contact: Audrey Hau 02071887188 ext 53821 firstname.lastname@example.org|