Clinical Study of Aneurysm Exclusion

NCT00549380 | Unknown Phase 1

• 1 other identifier: G990189
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The ultimate purpose is to explore potential techniques to exclude aneurysms and provide 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.

Conditions

Aneurysm

Keywords

Aneurysmal Disease in Thorax, Abdominal or Extremity

Outcome Measures

Primary Outcomes (1)

• Feasibility applications

  The primary objective of this study is to examine the feasibility of expanded applications of the basic Endologix technology for the treatment of arterial aneurysmal disease.

  Index procedure and discharge following index procedure

Secondary Outcomes (1)

• Data collection

  1 month

Study Arms (1)

1

EXPERIMENTAL

Device: Endologix, Inc. Endoluminal Technology

Interventions

Endologix, Inc. Endoluminal Technology DEVICE

Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Informed consent understood and signed.
• Compliance with post-treatment follow-up requirements.
• Candidates in this study may not be ideal surgical patients and therefore may be included based upon the recommendation of the principal investigator or co-investigators and one independent consultant confirming the opinion of the investigators.
• Patient may present as an emergency or urgent use patient with indications including: ruptured aneurysm, dissected artery, or transected artery.

You may not qualify if:

• Life expectancy \< 2 years.
• Pregnant or lactating women.
• Indication that appropriate follow-up studies would for whatever reason be difficult to obtain.
• Patient has other medical or psychiatric problems, which in the opinion of the investigator, precludes them from participating in the study.
• Anticoagulation drugs are indicated.
• Coagulopathy or bleeding disorder.
• Active systemic or localized groin infection.
• Inferior mesenteric artery is indispensable.
• Creatinine level \> 1.7 mg/dl.

Sponsors & Collaborators

• Arizona Heart Institute: lead

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Edward B Diethrich, M.D.

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: October 1, 1999
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 27, 2010

Record last verified: 2009-05

Locations

US (1)