NCT00233688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

3.1 years

First QC Date

October 5, 2005

Last Update Submit

April 30, 2009

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL

QUANTUM LP™ STENT GRAFT SYSTEM

Device: QUANTUM LP™ STENT GRAFT SYSTEM

2

ACTIVE COMPARATOR

Surgical intervention

Procedure: Open surgical repair

Interventions

QUANTUM LP™ STENT GRAFT SYSTEMDEVICE

Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

1
Open surgical repairPROCEDURE

Open surgical repair

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-emergent surgical candidate (aneurysm has not ruptured)
  • Patients 21 years of age or older
  • Male or infertile Female
  • Aneurysm \>/=4.5 cm in diameter, or
  • Aneurysm \>/= twice the normal aortic diameter directly above the aneurysm, or
  • Aneurysm \>/= 4.0 cm in diameter and rapidly growing (0.5 cm in 6 months), or
  • Saccular aneurysm \> 3.0 cm
  • Aneurysm starts \>/= 10 mm below the most distal main renal artery and the diameter of aorta within that aortic neck segment is not variable
  • Diameter of aortic fixation zone (neck) \>/= 22mm and \</= 30 mm
  • Supra renal aortic diameter \</= 34 mm
  • The required device coverage length \>/= 13 cm extending from most distal main renal artery ostium to the distal anchoring site within the common iliac artery (or external iliac artery if planned occlusion of internal iliac artery)
  • Aortic neck angulation \< 60° as estimated from CT scan images or angiogram
  • Iliac artery attachment zone diameter \</= 20 mm
  • Iliac arteries with a length of \>/= 10 mm of non-aneurysmal vessel located at the iliac graft attachment sites
  • Iliac arteries with adequate peripheral access to accommodate a 22 Fr catheter delivery system
  • +2 more criteria

You may not qualify if:

  • Weight \> 350 lbs. (159 Kg)
  • Mycotic, ruptured or traumatic aneurysm
  • Life expectancy \< 2 years
  • MI, cerebral vascular accident or transient ischemic attack (TIA) within 6 months
  • Expected occlusion or the need for re-implantation of significant mesenteric or renal arteries originating from the AAA
  • Aneurysm is symptomatic or tender
  • Creatinine \> 2.5 mg/dl or patient on dialysis
  • Thrombus in proximal and distal attachment area covering greater than 50% of the endoluminal surface

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • H. Wayne Hutman, MD

    Cordis US Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 6, 2005

Study Start

November 1, 2001

Primary Completion

December 1, 2004

Study Completion

April 1, 2009

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

US(1)