NCT00549016

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

10 years

First QC Date

October 24, 2007

Last Update Submit

May 14, 2009

Conditions

Aneurysm

Keywords

Aneurysm Exclusion

Outcome Measures

Primary Outcomes (1)

  • Technical success in the deployment and placement of the endoluminal graft to the aneurysmal site.

    1 month

Secondary Outcomes (1)

  • Acute success when the endoluminal graft excludes the aneurysm and maintain patency without endoleaks, migration or rupture.

    1 month

Study Arms (1)

1

EXPERIMENTAL
Device: PTPE Encapsulation of Nitinol Stents

Interventions

PTPE Encapsulation of Nitinol StentsDEVICE

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Edward B Diethrich, M.D.

    Arizona Heart Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Russell Williams

CONTACT

602-266-2200rwilliams@azheart.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

November 1, 2002

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

US(1)