CaveoVasc Thrombolysis Protection System, Access Protection Study

NCT03166059 | Unknown

• 1 other identifier: Caveomed-2017-05
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Thrombolysis

Keywords

Catheter directed thrombolysis (CDT)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Adverse Events at Discharge

  From consent to discharge (usually less than 48 hours from start of procedure)

• Adverse Events at 30 days

  At 30 follow-up visit

• CDT without early interruption due to access site complication

  Start to end of CDT procedure (usually less than 48 hours from start of procedure)

• Successful thrombolysis

  Start to end of CDT procedure (usually less than 48 hours from start of procedure)

• Pain at access site

  Start to end of lysis medication (usually less than 48 hours from start of procedure)

Study Arms (1)

Single arm

EXPERIMENTAL

CaveoVasc® Thrombolysis Protection System

Device: CaveoVasc® Thrombolysis Protection System

Interventions

CaveoVasc® Thrombolysis Protection System DEVICE

CaveoVasc® Thrombolysis Protection System for Femoral Artery Access and Protection in Patients Treated with Thrombolysis for Limb Ischemia

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CaveoMed GmbH: lead
• MedPass International: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: December 22, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share