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CaveoVasc Thrombolysis Protection System, Access Protection Study

NCT03166059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-22

No results posted yet for this study

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

Interventions

DEVICE

CaveoVasc® Thrombolysis Protection System

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

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • CaveoMed GmbH

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2018-01-31
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166059 on ClinicalTrials.gov