NCT03901872

Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis

Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis A Prospective, Multicentre Cohort Trial A Physician Initiated Research Study Request

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this initial proof of principle single arm cohort trial is to determine if contemporary endovascular venous intervention, compared with a 1:1 propensity-matched medical therapy arm of the ATTRACT trial, significantly reduces the 2-year occurrence of Post Thrombotic Syndrome (PTS) in subjects with symptomatic proximal Deep Vein Thrombosis (DVT).

Detailed description

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.

Conditions

• Thrombolysis
• Deep Vein Thrombosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-29
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2019-04-03
• Last updated: 2019-08-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study