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Aneurysm clinical trials

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NCT ID: NCT00522535 Completed - Clinical trials for Abdominal Aortic Aneurysms

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

PYTHAGORAS
Start date: April 2006
Phase: N/A
Study type: Interventional

Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°. Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months. Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group. Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.

NCT ID: NCT00513773 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Inflammation and Risk Prediction in Patients With Abdominal Aortic Aneurysm

Start date: July 2008
Phase: N/A
Study type: Observational

The purpose of this study is to better understand the role of inflammation in the pathophysiology of abdominal aortic aneurysm. In this study we hope to show better ways of predicting risk in this condition by using a combination of FDG-PET with CT.

NCT ID: NCT00507559 Completed - Clinical trials for Abdominal Aortic Aneurysms (AAA)

The Pivotal Study of the Aptus Endovascular AAA Repair System

STAPLE-2
Start date: September 2007
Phase: N/A
Study type: Interventional

A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).

NCT ID: NCT00488358 Completed - Clinical trials for Abdominal Aortic Aneurysm

Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Start date: November 2005
Phase: N/A
Study type: Observational

To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.

NCT ID: NCT00486226 Completed - Clinical trials for Intracranial Aneurysm

The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System

SUNRISE
Start date: June 1, 2007
Phase:
Study type: Observational

The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.

NCT ID: NCT00478803 Completed - Aortic Aneurysm Clinical Trials

Conservative Aortic Valve Surgery for Aortic Insufficiency and Aneurysms of the Aortic Root. CAVIAAR

CAVIAAR
Start date: May 2007
Phase: Phase 3
Study type: Interventional

The primary objective of the CAVIAAR study is to prove that aortic valve sparing for patients with aortic root aneurysms and/or dystrophic aortic insufficiency is associated with a 45% increase of 3 years-survival rate without increased mortality or serious increased morbidity events when compared to mechanical valve replacement. The main hypothesis of this study is that a standardized procedure of valve sparing based on external aortic annuloplasty in patients with dystrophic aortic insufficiency and/or aortic root aneurysm increases survival rate without increased mortality or serious increased morbidity events when compared with patients undergoing mechanical aortic valve replacement.

NCT ID: NCT00442065 Completed - Clinical trials for Abdominal Aortic Aneurysm

ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels

ARBITER-II
Start date: October 2006
Phase: Phase 2/Phase 3
Study type: Interventional

To assess the safety and performance of Aorfix™ 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.

NCT ID: NCT00435942 Completed - Clinical trials for Thoracic Aortic Aneurysms

Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Start date: January 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.

NCT ID: NCT00416000 Completed - Clinical trials for Abdominal Aortic Aneurysm

Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

Start date: January 2006
Phase: N/A
Study type: Observational

It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients have developed complications with lung and kidney function. This study will investigate certain biochemical processes that will potentially reduce these complications. Knowledge gained from this study may also be used to further research in this field through larger studies.

NCT ID: NCT00413231 Completed - Clinical trials for Thoracic Aortic Aneurysm

Valor II: The Valiant Thoracic Stent Graft System Clinical Study

Start date: December 2006
Phase: N/A
Study type: Interventional

This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.