InSeal Vascular Closure Device Clinical Study Protocol (VCD)

February 22, 2016 updated by: InSeal Medical Ltd.

The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.

The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60389
        • Cardio Vascular Centrum Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath.
  • Subject age is at least 18 years
  • Patient has signed most recent approved version of the Informed Consent
  • Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion Criteria:

  • Women Of Child Bearing Potential (WOCBP)
  • Legally non-competent patients
  • Patient participating in another clinical study at the time of the InSeal VCD study
  • Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization
  • Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure
  • Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment
  • Prior vascular surgery or vascular graft in region of access site
  • Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: InSeal's Vascular Closure Device
Use of the experimental VCD to close the access site of the artery
Device: InSeal's Vascular Closure Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second
Time Frame: 15 minutes
15 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
2. Combined rate of closure-device related major adverse events in first month
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSeal Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

July 6, 2013

First Submitted That Met QC Criteria

July 6, 2013

First Posted (ESTIMATE)

July 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-14-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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