The STAPLE International Post-Market Registry

October 27, 2021 updated by: Medtronic Cardiovascular

The STAPLE-International Post-Market Registry

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

Study Overview

Status

Status

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

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 Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.

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.
Observational

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.
108

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

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Sherbrooke University Hospital Centre
  • Germany
      • Berlin, Germany
        • German Heart Center
      • Frankfurt, Germany
        • Cardiovascular center Frankfurt
      • Lingen, Germany
        • St. Bonifatious Hospital
  • Greece
      • Athens, Greece
        • Hellenic Airforce Hospital
  • Italy
      • Siena, Italy
        • University of Siena
  • Netherlands
      • Nieuwegein, Netherlands, 3430
        • St Antonious Hospital
  • Spain
      • Barcelona, Spain
        • Thorax Institute Hospital Clinic
      • Pamplona, Spain
        • University of Navarra

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

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.

Description

Inclusion Criteria:

  1. Patient ≥ 18 years old
  2. Patient has given written informed consent
  3. Patient has a life expectancy > 1 year
  4. Patient is willing to comply with follow-up evaluations

  5. Patient's AAA meets at least one of the following criteria:

    • ≥ 4.5cm in diameter
    • Increased in size by 0.5cm in last 6 months
    • Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
    • Saccular aneurysm larger than 3cm in maximal diameter
  6. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
  7. Patient has a proximal aortic neck length of at least 12mm
  8. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
  9. Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm

Exclusion Criteria:

  1. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
  2. Patient has a symptomatic AAA
  3. Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
  4. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
  5. Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
  6. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
  7. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
  8. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Fortevo Endograft
All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment if treated with the Fortevo Endograft.
Device: Fortevo Endograft
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.

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
Technical Success
Time Frame: Within 24 hours of the Index procedure

The first primary endpoint is primary technical success. It consists of the following items:

  • Successful arterial access
  • Successful deployment of the Fortevo Endograft with secure proximal and distal fixation
  • Absence of type I or III endoleaks
  • Patent Fortevo Endograft without significant twist, kinking, or obstruction
Within 24 hours of the Index procedure
Major Adverse Events (MAE)
Time Frame: Within 1-Month of Implantation

The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events:

  • Death
  • Myocardial Infarction
  • Stroke (excludes TIA)
  • Renal failure (excludes renal insufficiency)
  • Respiratory Failure (excludes COPD or pulmonary complications)
  • Paralysis (excludes paraparesis)
Within 1-Month of Implantation

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
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Time Frame: 1-Month, 6-Months and 12-Months

Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of:

  • Death as a result of aneurysm-related treatment
  • Type I or III endoleak
  • Fortevo Endograft infection
  • Fortevo Endograft thrombosis
  • Fortevo Endograft dilatation by 20% or more in diameter
  • Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M
  • Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity
  • Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M
  • Aneurysm rupture
  • Conversion to open repair
1-Month, 6-Months and 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.
Medtronic Cardiovascular

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: Jean-Paul de Vries, MD, St Antonius Hospital - Nieuwegein, Netherlands

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.
August 1, 2010

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.
April 1, 2015

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.
June 19, 2015

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).
January 11, 2011

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.
January 11, 2011

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.
January 13, 2011

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.
November 2, 2021

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.
October 27, 2021

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.
October 1, 2021

More Information

Terms related to this study

Keywords

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.
  • CD03335-01

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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