Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)

Phase 3

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: QUANTUM LP™ STENT GRAFT SYSTEM; Procedure: Open surgical repair

• Registration Number: NCT00233688
• Lead Sponsor: Cordis Corporation

Brief Summary

The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-12
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-06
• Status Verified: 2009-04
• Study Completion: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	QUANTUM LP™ STENT GRAFT SYSTEM	QUANTUM LP™ STENT GRAFT SYSTEM
2	Open surgical repair	Surgical intervention

Primary Outcome Measures

Name	Time	Method
To compare the aneurysm-related one-year mortality rates of the stent graft patients to open surgery patients. The purpose of having an aneurysm surgically or endovascularly repaired is to prevent death from AAA.	One year
To compare the one-year procedure-related severe adverse event rates of the stent graft patients to open surgery patients. These events exclude aneurysm-related deaths. The endpoint for this objective will be the occurrence of any serious adverse eve	One year

Secondary Outcome Measures

Name	Time	Method
To evaluate the occurrence of severe device-related adverse events as they relate to the cause of aneurysm exclusion failures (i.e., Type I and III endoleaks, significant AAA growth, or AAA rupture).	30 days, 6 mo, and annually up to five years
To compare the rate and amount of blood products used in the stent graft procedure to open surgery.	At procedure

Trial Locations

Locations (1)

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States