EUCTR2014-000377-40-HU进行中（未招募）不适用
Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy Of MST-188 in Subjects with Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator - Evaluation of MST-188 in Acute Lower Limb Ischemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1. Written documentation of informed consent
- •2. Age =30 and <80 years
- •3. Symptoms consistent with acute ischemia in the target lower limb of =14 days’ duration and classified as Rutherford Category IIa or IIb
- •4. Subject is hospitalized or in the process of admission for the treatment of acute limb ischemia (ALI)
- •5. Angiographic confirmation of thrombotic lower limb arterial occlusion =10 cm in length
- •6. Planned recombinant tissue plasminogen activator (rt-PA) intra-arterial, catheter-directed thrombolytic therapy
- •7. Target lower limb transcutaneous oxygen tension (TcPO2) =40 mmHg
- •8. Ankle-brachial index (ABI) =0.60 in the target lower limb or, if vessels are incompressible as defined by ABI =1.40 then a toe-brachial index (TBI) =0.50
- •9. If sexually active, the subject agrees to use reliable contraception while participating in this study and for at least 30 days after discontinuation of blinded study drug infusion
- •10. If the subject is female and of child-bearing potential, must have negative pregnancy test (urine or serum)
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
- •2. Prior major amputation in the target limb
- •3. Inability to place a guidewire to the distal end of the occluding thrombus and position an infusion catheter into the thrombus
- •4. Thrombotic occlusion limited to the infrapopliteal arteries
- •5. Occlusion of all of the following tibial arteries on the baseline angiogram: anterior tibial, posterior tibial and peroneal
- •6. Thrombosis of or embolization deemed to be from a popliteal aneurysm by investigator
- •7. Motor loss with inability to dorsiflex the foot
- •8. Rhabdomyolysis and/or myoglobinuria
- •9. Embolization as the suspected cause of the arterial occlusion
- •10. Treatment with a thrombolytic agent within the last 48 hours
- •11. Subject has a known or suspected bleeding diathesis
- •12. Intracranial or spinal surgery or severe intracranial trauma within the last 3 months
- •13. History of hemorrhagic stroke, known intracranial neoplasm, aneurysm, or arteriovenous malformation
- •14. Thrombotic or embolic stroke within 6 months or transient ischemic attack within 3 months
- •15. Major surgery, intraocular surgery, organ biopsy, lumbar puncture, or puncture of an incompressible artery in the last 10 days
- •16. New York Heart Association Class IV congestive heart failure
- •17. Active gastrointestinal or other active organ bleeding
- •18. Uncontrolled arterial hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
- •19. Hemoglobin <8 g/dL
- •20. Subject’s international normalized ratio (INR) >1.7 and unable to be corrected prior to gaining arterial access
- •21. Subject has platelet count <75,000/mm3
- •22. Subject has hepatic dysfunction defined by alanine aminotransferase (ALT) >3-fold the institution’s upper limit of normal
- •23. Subject has a serum creatinine value >1.5 mg/dL or is on dialysis
- •24. Subject is pregnant or nursing
- •25. Current vascular graft infection
- •26. Subject is already hospitalized for any condition other than acute lower limb ischemia in the target limb
- •27. Subject is currently receiving another investigational drug or has received any investigational drug within 30 days prior to randomization
- •28. Any contraindications for receiving rt-PA, anticoagulants, or contrast media
- •29. Subject is otherwise not an appropriate study subject, in the Investigator's judgment
- •30. Subject has been previously randomized in the present trial or any prior MST-188 clinical trial
研究者
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