Clinical Study of the Medeon Biodesign XPro™

September 18, 2019 updated by: Medeon Biodesign, Inc.

Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System

To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
  • New Zealand
      • Auckland, New Zealand, 1142
        • Auckland City Hospital
      • Christchurch, New Zealand, 4710
        • Christchurch Hosptial
      • Hamilton, New Zealand
        • Waikato Hospital
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is > 18 years old
  • Patient is scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR involving access through the femoral artery using an 8-18 Fr introducer sheath
  • Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
  • Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
  • Patient is willing and able to complete follow-up

Exclusion Criteria:

  • Prior intra-aortic balloon pump at access site
  • Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%
  • Common femoral artery lumen diameter is < 6 mm
  • Prior target artery closure with any closure device < 90 days, or closure with manual compression ≤ 30 days prior to index procedure
  • Prior vascular surgery, vascular graft, or stent in region of access site
  • Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
  • Patients with significant anemia ((Hgb < 10 g/dL, Hct < 30%)
  • Patient with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
  • Patients with renal insufficiency (serum creatinine level > 221µmol/L) or renal transplant
  • Known allergy to contrast reagent
  • Inability to tolerate aspirin and/or other anticoagulation treatment
  • Planned anticoagulation therapy post-procedure such that ACT is expected to be elevated above 350 seconds for more than 24 hours after the procedure
  • Connective tissue disease (e.g., Marfan's Syndrome)
  • Thrombolytics (e.g. t-PA, streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
  • Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
  • Patients who are morbidly obese BMI > 40 kg/m2
  • Planned major intervention or surgery within 30 days following the interventional procedure
  • Patients who are unable to ambulate at baseline
  • Currently participating in a clinical study of an investigational device or drug that has not completed study endpoint
  • Known allergy to any device component
  • Patient is known or suspected to be pregnant or lactating
  • Life expectancy < 1 year as judged by the investigator
  • Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Intra-Procedure
  • Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
  • Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
  • Ipsilateral femoral venous sheath during the catheterization procedure
  • Common femoral artery calcium, which is fluoroscopically visible
  • Patients where there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
  • Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  • Evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site
  • Patients with intra-procedural bleeding around access site
  • Evidence of active systemic or local groin infection
  • Patients receiving glycoprotein IIb/IIIa inhibitors during, or after the catheterization procedure

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XPro System
Implantation of XPro System during percutaneous vascular closure
Device: XPro System
Implantation of the XPro System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Hemostasis
Time Frame: 15 minutes
Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
15 minutes
Freedom from major VARC-2 events
Time Frame: Up to 30 days of procedure
Freedom from major VARC-2 events within 30 days of the procedure.
Up to 30 days of procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from minor VARC-2 events
Time Frame: Up to 30 days of procedure
Freedom from minor VARC-2 events up to 30 days of the procedure.
Up to 30 days of procedure
Successful hemostasis with the XPro System
Time Frame: at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events.
at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Freedom from access-site infection
Time Frame: Up to 30 days of procedure
Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization.
Up to 30 days of procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to ambulation
Time Frame: Up to 48 hours
Defined as elapsed time from sheath removal and time when the patient stands and walks at least 20 feet without re-bleeding.
Up to 48 hours
Time to hospital discharge
Time Frame: Up to 2 weeks
Time to actual hospital discharge defined as elapsed time from sheath removal to actual physical discharge from the hospital.
Up to 2 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medeon Biodesign, Inc.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-LHC03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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