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Completed

NCT Number: NCT00233688

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

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

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Surgical Patients):

  • 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

Inclusion criteria

(Stent Graft Patients)

  • 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

Exclusion criteria

(Surgical and Stent Graft Patients):

  • 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

Exclusion criteria

(Stent Graft Patients only)

  • 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

Treatment and study plan

QUANTUM LP™ STENT GRAFT SYSTEM

Device

Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

open surgical repair

Procedure

Open surgical repair

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. To compare the rate and amount of blood products used in the stent graft procedure to open surgery.

    Time frame: At procedure

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Registry information

Official study title

A Prospective, Multicenter Study of the Cordis Endovascular QUANTUM LP™ Stent Graft System for the Treatment of Abdominal Aortic Aneurysms (AAA)-FORTRON

Important dates

Study start
2001
Primary completion
2004
Study completion
2009
First posted
Oct 6, 2005
Registry last updated
May 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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