EUCTR2006-005731-16-IE进行中（未招募）不适用
An Open Label Clinical Trial of Microplasmin Administered via the Trellis-8 Infusion System for the Treatment of Acute Iliofemoral Deep Vein Thrombosis
ThromboGenics Ltd.0 个研究点开始时间: 2006年11月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
不适用
An Open Label, Single Center Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion - MIVI 8Focal vitreomacular adhesionMedDRA version: 9.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndromeEUCTR2008-005228-10-BEThromboGenics NV
已完成
不适用
PK_AL_PREGNANCY_KENYAMalariaPACTR201211000451437Kenya Medical Research Institute75
尚未招募
2 期
A clinical trial to study the efficacy of Siddha formulation in patients with SinusitisCTRI/2013/08/003930Central Council for Research in Siddha30
尚未招募
2 期
To see if Telmisartan helps to improve the symtoms of Raynauds Phenomena (discoloration/pain in fingers on exposure to cold temperatures) in patients of Systemic sclerosis or MCTDCTRI/2024/07/069866Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
尚未招募
2 期
To check the efficacy if Telmisartan in Raynauds phenomenon associated with Systemic Lupus Erythematosus and Rheumatoid ArthritisCTRI/2024/07/069868Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005