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| Sponsored by: |
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 |
| MedlinePlus related topics: | Aneurysms |
| 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 |
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| Contact: William C Loan, M.D. | +44-28-9032.9241 | willie.loan@bch.n-i.nhs.uk |
| Czech Republic | |||||
| 2 Interni Klinika; General University Hospital | Not yet recruiting | ||||
| Prague, Czech Republic, 12800 | |||||
| Contact: Dr. Petr Varejka, MD | |||||
| Principal Investigator: Petr Varejka, MD | |||||
| Germany | |||||
| Klinik für Gefäßchirurgie; St.-Franziskus Hospital Münster | Recruiting | ||||
| Munster, Germany, 48145 | |||||
| Contact: Dr. Jorg Tessarek, MD | |||||
| Principal Investigator: Jorg Tessarek, MD | |||||
| Poland | |||||
| Department of Interventional Radiology, University School of Medicine | Recruiting | ||||
| Lublin, Poland, 20954 | |||||
| Contact: Prof. M. Trojanowska, MD | |||||
| Principal Investigator: M. Trojanowska, MD | |||||
| Spain | |||||
| Vascular Surgery Division, Thoracic Institute, Hospital Clinic, University of Barcelona | Recruiting | ||||
| Barcelona, Spain, 08036 | |||||
| Contact: Prof. Vincent Riambau, MD | |||||
| Principal Investigator: Vincent Riambau, MD | |||||
| United Kingdom | |||||
| Belfast City Hospital Trust | Recruiting | ||||
| Belfast, United Kingdom | |||||
| Principal Investigator: Willie Loan, MD | |||||
| Freeman Hospital; Main X-Ray | Recruiting | ||||
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |||||
| Contact: Dr. John Rose, MD | |||||
| Principal Investigator: John Rose, MD | |||||
| Lombard Medical |
| Principal Investigator: | William C Loan, MD, FRCR | Belfast City Hospital Trust, Belfast, Ireland |
More Information
| Study ID Numbers: | 2003-001P2 |
| First Received: | February 28, 2007 |
| Last Updated: | September 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00442065 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Comité Ético de Investigación Clínica |
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