E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Iliofemoral Deep Vein Thrombosis |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary purpose of this study is to evaluate the safety and efficacy of microplasmin administration using the Trellis-8 Infusion System in patients with acute iliofemoral DVT.
The primary objectives of this study are to: • Assess the degree of thrombus removal and flow restoration attained following administration of microplasmin using Trellis-8 Infusion System, via venography. • Assess patency of treated veins via duplex ultrasonography. • Examine symptom improvement for patients receiving index procedure (treatment) plus anticoagulation post index procedure. • Examine total thrombolytic dose and duration of thrombolytic therapy during index procedure. • Assess coagulation parameters and the incidence of bleeding and other adverse events pre, peri and post index procedure.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint/Efficacy Parameter: Treatment Success Target vessel segment treated using microplasmin administered via the Trellis-8 Infusion System demonstrates less than or equal to 25% residual thrombus AND flow is present following administration of microplasmin via the Trellis-8 Infusion System, before any adjunctive manoeuvres to address underlying disease or residual thrombus. This will be assessed during the interventional procedure, based on venography.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |