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Sponsored by: |
Lombard Medical |
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Information provided by: | Lombard Medical |
ClinicalTrials.gov Identifier: | NCT00442065 |
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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 2003-001P2 |
Study First Received: | February 28, 2007 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00442065 |
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 Abdominal aortic aneurysm |
Vascular Diseases Iliac Aneurysm Aortic Aneurysm |
Cardiovascular Diseases |