The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study

NCT ID: NCT00753337

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2013-09-30

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).

Detailed Description

This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assurant Cobalt Iliac Stent

Assurant® Cobalt Iliac Stent System

Group Type: EXPERIMENTAL

Assurant® Cobalt Iliac Stent System

Intervention Type: DEVICE

Iliac Stenting

Interventions

Assurant® Cobalt Iliac Stent System

Iliac Stenting

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery;
• The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
• The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
• The lesion length is < 100 mm (10 cm)

Exclusion Criteria

• Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified.
• Tissue loss in the target extremities.
• The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
• The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement;
• Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s).
• Inadequate distal run-off.
• History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
• Creatinine > 2.5 mg/dl
• Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3
• Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints;
• Previously enrolled in the Study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Molnar, MD

Role: PRINCIPAL_INVESTIGATOR

Michigan Vascular Research Center

William Gray, MD

Role: PRINCIPAL_INVESTIGATOR

NY Presbyterian Hospital

Locations

Michigan Vascular Research Center

Flint, Michigan, United States

NY Presbyterian Hospital

New York, New York, United States

Countries

United States

References

Molnar RG, Gray WA; ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013 Feb;20(1):94-103. doi: 10.1583/12-4010.1.

Reference Type: DERIVED

PMID: 23391088 (View on PubMed)

Other Identifiers

IP085

Identifier Type: -

Identifier Source: org_study_id