Clinical Study of Aneurysm Exclusion (EndoMed)

May 14, 2009 updated by: Arizona Heart Institute

Clinical Study of Aneurysm Exclusion Using PTFE Encapsulation of Nitinol Stents

The ultimate purpose is to explore the potential techniques to exclude aneurysms and provide an alternative conduit for arterial flow. The single center sponsorship is intended to provide the investigators the potential to incorporate improvements in existing technology during the course of the study thereby ultimately enhancing the potential for superior medical care of patients suffering from these disease states. The sponsor/investigator recognizes and accepts responsibility to notify and receive approval from the agency when device modifications are made that may affect patient safety.

Study Overview

Status

Status

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

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 Arizona Heart Institute is respectfully submitting this protocol for a feasibility study utilizing the endoluminal grafts constructed of PTFE encapsulated nitinol stents. The study is intended to evaluate the use of this unique device in the treatment of aortic aneurysmal disease. The stent graft is made by laminating a PTFE "jacket" around nitinol stents which act as structural and fixation supports. Both materials have an extensive history of use in various types of implanted devices. CT scans and angiography or 3D computer imaging, and possibly IVUS imaging will be used to choose the sites for placement of the devices and to assure precise deployment.

In comparison to the conventional surgical approach, endoluminal stent-graft techniques for repair of abdominal aortic aneurysms (AAAs) offer the advantages of a minimally invasive procedure with lower morbidity and perhaps cost reduction. The Arizona Heart Institute has a long history in the area of endoluminal grafting for treatment of aneurysms and occlusive disease. Endoluminal sleeves principally using ePTFE and both stainless steel and nitinol stent structures have been studied using commercially available materials customized for particular pathologic situations. As the technology advances however, sophisticated engineering beyond the capabilities of our institution was required.

The proposed project originates because of the potential to escalate the combination of ePTFE and stents to a higher level of performance in aneurysm exclusion procedures. Current data reflect several deficiencies in approved exclusion devices. Migration, types I, II and III endoleaks and continual aneurysm expansion are clear predictors for potential ruptures. Increased complications associated with the initial peri-procedural deployment as devices are released on a broader scale have been observed. In order to address these problems, the Arizona Heart Institute has engaged EndoMed engineering to design the endoluminal graft to repair abdominal aortic aneurysms. We believe this will result in a positive step forward in the technology to exclude aneurysmal disease less invasively.

The endoluminal stent-graft is composed of multiple nitinol stents which are encapsulated in expanded Polytetrafluoroethylene (ePTFE). The stents are composed of a Z-shaped, performed nitinol wire, which is crimped together with a stainless steel sleeve to form the circular frame of the graft. This frame is then encapsulated between two thin sheets of laminated PTFE. The proximal end of the endoluminal stent-graft is made in two configurations. One is a completely encapsulated graft where the PTFE covers the entire device. The other has an open stent segment (bare wire configuration) that allows the open stent region of the graft to be placed across the orifice of the renal, mesenteric, or internal iliac arteries without obstructing antegrade blood flow. The device will be available in a straight tube, aortomonoiliac or bifurcated design.

Once the endoluminal stent graft is built, a 4 French guidewire dilator is placed through the center of the graft and the assembly is compressed into a high density polyethylene (HDPE) cartridge for ease of intraluminal delivery. The endoluminal stent-graft is then placed in two Tyvek pouches and sterilized using Hydrogen Peroxide.

Subjects will undergo an evaluation of the PTFE encapsulation of Nitinol stents to provide data on the device's feasibility for therapeutic clinical use. Follow-up will be completed at 1, 6, 12, 24, 36, 48, and 60 months. Subject evaluation at 1 month will include a Complete History and Physical, Bilateral ABIs, Abdominal Duplex Ultrasound, and a KUB X-ray (4 views). Subject evaluation at 6 months will also include a Complete History and Physical, Bilateral ABIs, Abdominal Duplex Ultrasound, KUB X-ray (4 views), and based on the duplex ultrasound an Abdominal CT scan with and without IV contrast 2.5 mm and Labs (BUN/Creatinine). Subject evaluation at 12, 24, 36, 48, and 60 months will include a Complete History and Physical, Bilateral ABIs, Abdominal CT scan with and without IV contrast 2.5 mm, Abdominal Duplex Ultrasound, KUB X-ray (4 views), and Labs (BUN/Creatinine).

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 (Anticipated)

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.
150

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Arizona Heart Institute
        • Sub-Investigator:
          • Julo Rodriguez-Lopez, M.D.

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:

  • Aneurysm diameter ≥ 4.0 cm; or aneurysm diameter ≤ 4.0 cm which has exhibited rapid expansion; or aneurysms with saccular configuration where potential for rupture is increased; or aneurysms which have exhibited dissection and there is potential for rupture or compromised flow to vital structures; or symptomatic leaking or ruptured aneurysms.
  • Vessels proximal and distal to the lesion must be capable of accommodating the device.
  • The access artery diameter and profile of the artery must be capable of the device delivery.
  • Patients must be ASA III or higher.
  • Informed consent must be obtainable.
  • Patients must be willing and able to comply with the follow-up regime.
  • Patients with neck grades as follow:
  • Grade I: Length of Proximal Neck ≥ 1.5 cm and Distal Neck ≥ 1.0 cm
  • Grade II: Length of Proximal Neck ≥ 1.5 cm, but Distal Neck < 1.0 cm without obvious iliac aneurysms, or aneurysm extends into or is associated with iliac aneurysms.
  • Grade III: Length of Proximal Neck < 1.5 cm and Distal Neck ≥ 1.0 cm
  • Grade IV: Length of Proximal Neck < 1.5 cm and Distal Neck < 1.0 cm or the involvement as in Grade II.

Exclusion Criteria:

  • A proximal neck less than 0.5 cm in length.
  • Arterial diameter larger than 40 mm at the proximal or distal landing zones.
  • Iliac diameter less than 6 mm (following balloon angioplasty as needed).
  • The inferior mesenteric artery is indispensable.
  • Patients under the age of 18.
  • Pregnant or lactating women.
  • Patients with allergy to any of the device materials.
  • Patients with uncorrectable coagulopathy or bleeding disorders.
  • Patients for whom contrast medium or anticoagulation drugs are contraindicated.
  • Patients with active systemic or localized groin infection.

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

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: 1
Device: PTPE Encapsulation of Nitinol Stents
Both common femoral arteries (CFAs) are surgically exposed to allow bilateral access of diagnostic and therapeutic devices. The endoluminal stent graft is then deployed in accordance with the Instructions for Use.

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
Time Frame
Technical success in the deployment and placement of the endoluminal graft to the aneurysmal site.
Time Frame: 1 month
1 month

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
Time Frame
Acute success when the endoluminal graft excludes the aneurysm and maintain patency without endoleaks, migration or rupture.
Time Frame: 1 month
1 month

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.
Arizona Heart Institute

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.
November 1, 2002

Primary Completion (ANTICIPATED)

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.
November 1, 2012

Study Completion (ANTICIPATED)

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.
November 1, 2012

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).
October 24, 2007

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.
October 24, 2007

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.
October 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

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.
May 15, 2009

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.
May 14, 2009

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.
May 1, 2009

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.
  • G020035

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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