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| Sponsor: | Lombard Medical |
|---|---|
| Information provided by: | Lombard Medical |
| ClinicalTrials.gov Identifier: | NCT00442065 |
Purpose
To assess the safety and performance of AorfixTM Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries.
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Aortic Aneurysm |
Device: AorfixTM Stent Grafts (AAA endovascular procedure) |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Study to Assess the Acute Technical Success of AorfixTM Stent Grafts in the Treatment of Abdominal Aortic and Aorto-Iliac Aneurysm Where a Significant Degree of Vessel Angulation Exists at the Neck of the Aneurysm |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
The AorfixTM Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is <65o. The objective of this study is to evaluate the safety and performance of the bifurcated AorfixTM Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms, in infrarenal necks angulated > 60o (between 60 to 90 degrees) as measured by 3-dimensional reconstruction in order to widen the indication.
The investigation is a prospective open label, single arm, multi-centre clinical study. The study group will consist of 25 evaluable participants. In order to account for patients lost to follow up (estimated at approximately 20%) up to 30 patients will be enrolled in the study.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| 2 Interni Klinika; General University Hospital | |
| Prague, Czech Republic, 12800 | |
| Germany | |
| Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster | |
| Munster, Germany, 48145 | |
| Poland | |
| Department of Interventional Radiology, University School of Medicine | |
| Lublin, Poland, 20954 | |
| Spain | |
| Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona | |
| Barcelona, Spain, 08036 | |
| United Kingdom | |
| Belfast City Hospital Trust | |
| Belfast, United Kingdom | |
| Freeman Hospital; Main X-Ray | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Principal Investigator: | William C Loan, MD, FRCR | Belfast City Hospital Trust, Belfast, Ireland |
More Information
| Study ID Numbers: | 2003-001P2 |
| Study First Received: | February 28, 2007 |
| Last Updated: | September 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00442065 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Comité Ético de Investigación Clínica |
|
Abdominal aortic aneurysm study |
|
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Aneurysm |