Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta

June 29, 2017 updated by: Atrium Medical Corporation
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.

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

The performance metric for comparison is based on data from the Congenital Cardiovascular Interventional Study Consortium (CCISC) as reported by Golden and Hellenbrand [1]. The CCISC experience from 1989 to 2005 shows a true procedural success rate of 98.6%.

The patient population will be subjects with coarctation of the aorta. A total of 70 subjects, children, adolescents and adults, will be enrolled at up to 15 study sites. Baseline clinical and angiographic assessment will determine the subject's eligibility for enrollment in the study. Subjects will continue in the study for long term annual follow-up through 3, 4, and 5 years.

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.
70

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
      • Sydney, Australia, 2145
        • The Children's Hospital at Westmead
  • Brazil
      • Sao Paulo, Brazil, 04012-180
        • Instituto Dante Pazzanese de Cardiologia
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children Labatt Family Heart Centre
  • Germany
      • Berlin, Germany
        • Heart Institute Berlin
      • Frankfurt, Germany, 60389
        • Cardiovascular Center
      • Sankt Augustin, Germany, 53757
        • Asklepios Klinik Sankt Augustin
  • Israel
      • Petach Tikva, Israel
        • Schneider Children's Medical Center
  • Italy
      • Milan, Italy
        • San Donato Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children and Bristol Royal Infirmary

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography.
  • Subject weighs a minimum of 30 kg.
  • The peak pressure gradient is ≥20 mmHg systolic blood pressure across the coarctation site.
  • Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon.
  • Coarctation can be successfully crossed with a guide wire, sheath and device.
  • Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter.
  • Subject is able and willing to adhere to all required follow-up visits and testing.
  • Subject is able and willing to adhere to the required follow-up medication regimen.

Exclusion Criteria:

  • The physician is not able to access the coarctation with standard techniques.
  • Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure.
  • Length of coarctation is greater than 45 mm in length.
  • Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome.
  • The coarctation has adjacent, acute thrombus.
  • The coarctation was previously treated with a stent.
  • Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta™ V12 Covered Stent device (e.g. "jailing" of the branch vessel).
  • Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta™ V12 Covered Stent
  • Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, expanded polytetrafluoroethylene (ePTFE) or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications.
  • Bloodstream infection
  • Subject is pregnant or breastfeeding.
  • Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
  • The investigator deems the subject to be an inappropriate candidate for the study.
  • Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.

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: Investigational Group
Use of Large Diameter Advanta™ V12 Covered Stent.
Device: Large Diameter Advanta™ V12 Covered Stent
Stent placement

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
Primary Efficacy
Time Frame: 12 month
The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).
12 month
Primary Safety
Time Frame: 30 days of procedure
30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
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
Secondary Safety
Time Frame: procedural (time zero)
Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
procedural (time zero)
Secondary Safety
Time Frame: 12 month
No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
12 month
Secondary Safety
Time Frame: 12 months
Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
12 months

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.
Atrium Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elchanan Bruckheimer, MD, Schneider Children's Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
September 1, 2009

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.
May 1, 2013

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.
April 1, 2017

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).
September 14, 2009

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.
September 16, 2009

First Posted (Estimate)

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.
September 17, 2009

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.
July 2, 2017

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.
June 29, 2017

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.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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