Abdominal Aortic AneurysmPhase 3NCT00233688
Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
A Phase 3 study testing QUANTUM LP™ STENT GRAFT SYSTEM and Open surgical repair in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. at 1 site in United States.
Trial summary
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- QUANTUM LP™ STENT GRAFT SYSTEM and Open surgical repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- Saccular aneurysm > 3.0 cm
- Patient meets all inclusion criteria for surgical candidate
- 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
- Aortic bifurcation > 18 mm in diameter
- Creatinine level < 2.5 mg/dl
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
About this study
Official title: A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- QUANTUM LP™ STENT GRAFT SYSTEM, Open surgical repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUANTUM LP™ STENT GRAFT SYSTEMDevice
Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Open surgical repairProcedure or surgery
Open surgical repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | QUANTUM LP™ STENT GRAFT SYSTEM Receives: Device: QUANTUM LP™ STENT GRAFT SYSTEM |
| 2 | Active comparator | Surgical intervention Receives: Procedure: Open surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startNov 2001
- Primary completionDec 2004
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H. Wayne Hutman, MD, Study director, Cordis US Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233688
- Sponsor's protocol ID
- P01-4601
- Status last verified
- Apr 2009
- First submitted
- 5 Oct 2005
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON
- ClinicalTrials.gov ID
- NCT00233688
- Acronym / sponsor ID
- P01-4601
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Dec 2004 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: QUANTUM LP™ STENT GRAFT SYSTEMQUANTUM LP™ STENT GRAFT SYSTEM |
| 2 | Active comparator | Procedure: Open surgical repairSurgical intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUANTUM LP™ STENT GRAFT SYSTEMStent Graft System for the Treatment of Abdominal Aortic Aneurysms | Device | 1 |
| Open surgical repairOpen surgical repair | Procedure or surgery | 2 |
Primary outcome
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.
Time frame: 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
Time frame: One year
2 secondary outcomes
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).
Time frame: 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.
Time frame: At procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Wayne Hutman, MD study director
Cordis US Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QUANTUM LP™ STENT GRAFT SYSTEM and Open surgical repair in people with Abdominal Aortic Aneurysm, run by Cordis US Corp. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2009.