Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality

Exclusion Criteria

• •1. CVAD (any type) used for hemodialysis;
• •2. CVAD known to be dysfunctional for more than 48 hours;
• •3. Reasonable evidence of mechanical or non-thrombotic occlusion in the selected study catheter (e.g., catheter malposition or migration, sutures, kinks, or precipitates causing obstruction), radiographic assessment is not required;
• •4. Known or suspected catheter related bloodstream infection (CRBSI);
• •5. Use of any fibrinolytic agent or anticoagulant (e.g., alteplase, tenecteplase, reteplase, urokinase or heparin) within 24 hours prior to the treatment period (first instillation of study drug). Use of subcutaneous low molecular weight heparin (LMWH) for prophylaxis of thromboembolic events is allowed;
• •6. Known to be at high risk for bleeding events or embolic complications in the opinion of the Investigator, or has a known condition for which bleeding constitutes a significant hazard (e.g. recent stroke, recent intracranial or intraspinal surgery or serious head trauma, intracranial neoplasm, arteriovenous malformation or aneurysm, known bleeding diathesis);
• •7. Uncontrolled hypertension (systolic BP ≥160 or diastolic BP ≥110 mmHg) at screening;
• •8. Clinically unstable in the opinion of the site investigator;
• •9. Known to be pregnant or breastfeeding at screening;
• •10. Previously treated in this study (READY 1) or in study READY 2;
• •11. History of allergic reaction to reteplase, alteplase or vial ingredients (excipients or diluents);
• •12. Use of any investigational drug or experimental medical device within 28 days prior to treatment; non interventional observational studies participation is allowed.
• •13. Not mentally, socially, or otherwise able to complete the trial assessment or not likely to survive beyond 30 days.