Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00549380
Other study ID # G990189
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received October 24, 2007
Last updated May 25, 2010
Start date October 1999
Est. completion date October 2010

Study information

Verified date May 2009
Source Arizona Heart Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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. A second objective of this study is to gather data in order to make logical, scientific recommendations for device design, construction and application which will expand the application of the endoluminal graft technology and improve its safety and efficacy while expanding the several potential future positive aspects of a less invasive method of treating arterial occlusive disease.

Endologix, Inc. has applied for and received an IDE for the investigation of a bifurcated device to exclude aneurysms of the abdominal aorta. The Arizona Heart Institute experience indicates that this small study design will prove successful. Using the basic technology of the current approved IDE, it is Arizona Heart Institute's intention to expand the scope of application and design in order to address a greater population basis suffering from aneurysmal disease. In this regard, the basic Endologix device designs will be applied to appropriate patients beyond the scope of the current bifurcated IDE. Patients meeting the criteria for the Endologix IDE will be enrolled independently in that study and followed precisely in order to comply with the study design. Patients with aneurysmal disease not currently filling the criteria for a bifurcated abdominal aortic prosthetic but who could potentially benefit from the technology to exclude aneurysmal disease will be considered from this study.

The patient's participation in the Study will include enrollment, Investigational Device procedure and follow-up period. Patient data will be collected for 1, 6, and 12 months and beyond as indicated. Subject follow-up at 1 month will include; ABIs, a complete Physical Examination, Duplex Ultrasound, and X-ray. Subject follow-up at 6 and 12 months will also include ABIs, a complete Physical Examination, CT Scan-Contrast Enhanced (unless contraindicated), CT Scan-No Contrast, and X-ray.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 88
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- = 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.

Exclusion Criteria:

- 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Endologix, Inc. Endoluminal Technology
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.

Locations

Country Name City State
United States Arizona Heart Institute Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arizona Heart Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Data collection A secondary objective of this study is to gather data in order to make logical, scientific recommendations for device design, construction, and application which will: a) expand the application of the endoluminal graft technology and b) improve its safety and efficacy while c) expanding the several potential future aspects of a less invasive method of treating arterial disease. 1 month No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06235619 - Arch Size Study for Anatomical Variations
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Not yet recruiting NCT00905931 - Lycopene Following Aneurysmal Subarachnoid Haemorrhage Phase 2
Completed NCT00349908 - A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries Phase 1
Recruiting NCT03285100 - The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation N/A
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Active, not recruiting NCT04592185 - The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Completed NCT01970605 - Silver Graft All Comers Registry
Completed NCT00282893 - Balloon Prophylaxis of Aneurysmal Vasospasm Phase 2
Completed NCT04598802 - COvera in BRAnch Registry
Completed NCT04246125 - Patient Skin Dose in Interventional Radiology
Recruiting NCT05829746 - PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS N/A
Completed NCT03242343 - VasQ External Support for Arteriovenous Fistula N/A
Recruiting NCT02878967 - Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm
Active, not recruiting NCT02345005 - Iliac Branch Excluder ReGistry (IceBERG)
Recruiting NCT02167997 - EffectiveNess and SAfety of Small ANeurysm COiling Trial N/A
Recruiting NCT00549016 - Clinical Study of Aneurysm Exclusion N/A
Completed NCT02848612 - Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Enrolling by invitation NCT04269447 - Prospective Aortic Biobank of POP-STAR
Recruiting NCT03496415 - The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy Phase 2/Phase 3