Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)

Abdominal Aortic Aneurysm Clinical Trial

Official title:

An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235118
• Other study ID #: P98-4601
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 6, 2005
• Last updated: December 8, 2005
• Start date: December 1999
• Est. completion date: February 2006

Study information

• Verified date: October 2005
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Anatomic (stent-graft)

Aortic Aneurysm Diameter

• > 4.5 cm

• Those aortic aneurysms < 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.

• Aorto-iliac aneurysms in which the aortic aneurysm is < 4.5 cm but the iliac artery aneurysms are > 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms < 3.0 cm.

• Saccular aortic aneurysms > 3.0 cm.

Aortic Neck

• Diameter > 17 mm and < 28 mm (Phase I)

• Diameter > 14 mm and < 28 mm (Phase II)

Angulation Neck Length < 45° > 15 mm <60° > 25 mm

Iliac Arteries

• Diameter > 8 mm and < 18 mm (Phase I and Phase II)

• At least one common iliac artery with a cuff > 15 mm.

Diameter Aortic Neck Common Iliac 26-28 mm 13–18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9–15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm

*NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).

Anatomic (surgical controls)

· Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria.

Aortic Aneurysm Diameter

• > 4.5 cm

• Those aortic aneurysms <4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.

• Aorto-iliac aneurysm in which the aortic aneurysm is <4.5 cm but the iliac artery aneurysm are >3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms <3.0 cm.

• Saccular aortic aneurysms > 3.0 cm.

• Clinical (stent-graft)

• Males and non-pregnant females > 40 years of age.

• Clinical (surgical controls)

Surgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria.

Exclusion Criteria:

Anatomic (stent-graft)

Aortic Aneurysm Diameter

· < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.

Aorto-iliac Aneurysms

• < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).

• The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device.

Aortic Neck

• Diameter < 17 mm and > 28 mm (Phase I)

• Diameter < 14 and >28 (Phase II)

• Thrombus lined

• Highly calcified

• NOTE: See inclusion criteria for length below the renals and degree of angulation.

Iliac Arteries

• < 8 mm and > 18 mm (native) (Phase I and Phase II)

• Highly calcified (common)

• Neither common iliac artery with a cuff > 15 mm.

• NOTE: See inclusion criteria for aortic neck and iliac artery diameters.

Anatomic (surgical controls)

· Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria.

Aortic Aneurysm Diameter

· < 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.

Aorto-Iliac Aneurysms

• < 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).

• The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries.

Clinical (stent-graft)

1. Ruptured abdominal aortic aneurysm.

2. Renal insufficiency – creatinine level > 2.5 mg/dl.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Cordis AAA Bilateral Device

Locations

Country	Name	City	State
United States	Mt. Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.
Primary	The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.
Secondary	· Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.
Secondary	·