CaveoVasc Thrombolysis Protection System, Access Protection Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Thrombolysis

Intervention / Treatment
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* Device: CaveoVasc® Thrombolysis Protection System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>CaveoVasc® Thrombolysis Protection System | Device: CaveoVasc® Thrombolysis Protection System<br>* CaveoVasc® Thrombolysis Protection System for Femoral Artery Access and Protection in Patients Treated with Thrombolysis for Limb Ischemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all major bleeds from the start of the CDT procedure to the end of the CDT procedure | BARC type > 3, as follows: Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed). Any transfusion with overt bleeding. Type 3b Overt bleeding plus hemoglobin drop >5 g/dL* (provided hemoglobin drop is related to bleed), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), bleeding requiring intravenous vasoactive agents. Type 3c Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), subcategories confirmed by autopsy or imaging or lumbar puncture, intraocular bleed compromising vision. (Type 4: CABG-related bleeding is not applicable for this study) Type 5: fatal bleeding Type 5a Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation. | Start of the CDT procedure to the end of the CDT procedure (usually less than 48 hours) | 
| Duration of CDT procedure | Hours | Start of the CDT procedure to the end of the CDT procedure (usually less than 48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events at Discharge | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. | From consent to discharge (usually less than 48 hours from start of procedure) | 
| Adverse Events at 30 days | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. | At 30 follow-up visit | 
| CDT without early interruption due to access site complication | Rate | Start to end of CDT procedure (usually less than 48 hours from start of procedure) | 
| Successful thrombolysis | Rate of successful thrombolysis without bleeding complication | Start to end of CDT procedure (usually less than 48 hours from start of procedure) | 
| Pain at access site | verbal pain scale (0 to 10), at start of CDT (time when infusion of lysis medication started), after 6 hours of start of CDT, and at the end of the CDT treatment (time when infusion of lysis medication has stopped) | Start to end of lysis medication (usually less than 48 hours from start of procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter directed thrombolysis (CDT)