CaveoVasc Thrombolysis Protection System, Access Protection Study

Prospective, Single Arm, Study to Assess the Safety and Performance of the CaveoVasc® Thrombolysis Protection System, for Femoral Artery Access and Protection in Patients Treated With Thrombolysis for Limb Ischemia

The CaveoVasc Thrombolysis Protection System is intended to aid sheath access and reduce bleeding complications during catheter directed thrombolysis (CDT) in the treatment of limb ischemia. This device has been designed to protect the puncture site by stabilizing the CDT sheath with the double-balloons that are part of the CaveoVasc system. Also the device is designed to reduce bleeding at the puncture site during CDT.

This study is designed to assess the safety and performance of the CaveoVasc Thrombolysis Protection System in twenty patients with limb ischemia undergoing treatment with CDT.

Catheter directed thrombolysis (CDT) is a non-surgical option for many patients, which involves the insertion of an infusion catheter (via the femoral artery) into the thrombus allowing for slow delivery of a pharmacological thrombolytic agent. Insertion of the infusion catheter is performed in the catheterization laboratory. The patient is usually then transferred to the intensive care unit, with delivery catheter in place and the infusion running for at least 24 hours.

The major complications reported with CDT include major and minor bleeding, and complications secondary to early termination of the CDT due to access site bleeding.

CaveoMed developed the CaveoVasc® Thrombolysis Protection System, a vascular access protection device intended for use in thrombolysis procedures. Its function is to facilitate sheath access, and minimize risks of access site bleeding complications during lengthy catheter-directed thrombolysis procedures. Pressure balloons inflated outside the artery maintain a good seal throughout thrombolysis, which typically lasts up to 24 hours. The thrombolysis catheter is then removed, and hemostasis at the site is managed per the hospital's standard.

The CaveoVasc® Thrombolysis Protection System design has important advantages for use during CDT procedures (which require long catheter dwell times). The system is intended to protect from intra-procedural bleeding at the arterial access site, which currently remains a major problem for patients with critical limb ischemia undergoing CDT treatment. This protection would lower the rate of bleeding events, and increase the rate of completed intended therapy, without interruption of the CDT treatment due to bleeding complications.

Inclusion Criteria:

• Adults > 18 years
• Diagnosis of limb ischemia requiring CDT
• Patient understands and signs the study specific written informed consent form

Exclusion Criteria:

• Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period
• Patients who cannot adhere to or complete the investigational protocol for any reason
• Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance)
• Patients with bleeding disorders such as thrombocytopenia (platelet count<100,000/mm3), hemophilia, von Willebrand's disease or anemia (Hgb <10g/ dL, Hct < 30%)
• Patients who need a puncture needle longer than 8 cm due to morbid obesity
• Patients who are cachectic and do not have enough subcutaneous tissue/fat to accommodate the CaveoMed device (the two balloons, with 2 ml of contrast-enriched saline in each ballon)
• Patients who are pregnant or lactating
• Patients with documented INR > 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors, unless the glycoprotein IIb/IIIa platelet inhibitor is given as a bolus prior to the CDT as part of the institution's standard of care