An Open Label Clinical Trial of Microplasmin Administered via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis

• Conditions: Acute Iliofemoral Deep Vein Thrombosis

• Registration Number: EUCTR2006-005731-16-IE
• Lead Sponsor: ThromboGenics Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient must meet all of the following criteria, in order to be included in the study:
a) Patient is at least 18 years old.
b) Patient has clinical manifestations (i.e. symptoms and/or signs) of acute DVT of the lower extremity.
c) Duration of leg symptoms <14 days of presentation.
d) Ultrasound confirmation of venous thrombus located in the iliac and/or femoral vein, with or without popliteal vein involvement.
e) In the opinion of the Investigator, obstructed vessel calibre can accommodate an 8FR System, from insertion site to target segment (e.g. vessel diameter > 2.75 mm).
f) Women of child-bearing potential must have a negative pregnancy test prior to enrollment and be using a reliable form of contraception.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

If the patient has any of the following criteria, they must be excluded from the study:
a) Isolated calf or popliteal vein DVT, based on duplex ultrasound.
b) Thrombus involving the inferior vena cava (IVC).
c) Proximal (e.g. cranial) aspect of thrombus cannot be adequately assessed to level of the iliac veins or inferior vena cava, based on duplex ultrasound.
d) Cannot traverse the target vessel segment with guidewire.
e) Symptomatic pulmonary embolism is present at time of presentation.
f) Documented history of prior DVT in target extremity
g) History of anticoagulants administered for greater to or equal to 30 days for undocumented/ unclear reason (e.g. for other than presence of mechanical cardiac valve, atrial fibrillation, etc.).
h) Documented history of thrombophilic disorder, with diagnosis established via previous objective testing (e.g. familial screening for thrombophilia).
i) Cannot receive standard secondary prevention pharmacotherapy [i.e. heparin or LMWH and vitamin K antagonists (VKA)] due to contraindications to anticoagulation [e.g. known bleeding diathesis, thrombocytopenia (platelets < 100,000 mm3), heparin induced thrombocytopenia (HIT), known allergy to heparin or warfarin]
j) Absolute contraindication to thrombolytic therapy, defined as:
•Suspected aortic dissection
•Acute pericarditis
•Active bleeding
•Known cerebral neoplasm
•Known intracranial vascular lesion
•Previous central nervous system haemorrhage
k) Receiving or received thrombolytic therapy within 24 hours prior to planned index procedure.
l) Documented intracranial or intraspinal tumour, or a tumour has invaded target limb vasculature or is causing extrinsic compression of target vessel segment.
m) Life expectancy less than 1 year, due to other comorbid condition.
n) Previous intervention in target limb to address venous thrombus.
o) Intracranial or intraspinal surgery within the past 3 months, or other major surgery (e.g. pelvic, abdominal) within 10 days prior to planned index procedure
p) Target limb has chronic venous insufficiency of C4 or greater severity
q) Acute or chronic symptomatic musculoskeletal condition in target limb (e.g. trauma, fracture, severe arthritis).
r) Documented patent foramen ovale or other right-to-left cardiac shunt.
s) Absolute contraindication to contrast media or renal insufficiency (baseline creatinine >2.0 mg/dL).
t) Unwilling or unable to provide informed consent, or return for required follow-up evaluations.
u) Previous participation in this study.
v) Patient has participated in another investigational study within the previous 30 days.
w) Pregnancy, nursing, positive or indeterminate pregnancy test, women of child-bearing potential not using an adequate form of contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified