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

NCT00235118 | Completed Phase 1

• 1 other identifier: P98-4601
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• · 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.

Interventions

Cordis AAA Bilateral Device DEVICE

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Michael Marin, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: December 1, 1999
• Study Completion: February 1, 2006
• Last Updated: December 9, 2005

Record last verified: 2005-10

Locations

US (1)