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

The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Assurant® Cobalt Iliac Stent System

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Research Center
  • New York
    • New York, New York, United States, 10032
      • NY Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Assurant Cobalt Iliac Stent; Assurant® Cobalt Iliac Stent System	Device: Assurant® Cobalt Iliac Stent System; Iliac Stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).	Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency Rate at 9 Months	Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.	9 months
Device Success	Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.	9 months
Lesion Success	Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.	9 months
Procedure Success	Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)	9 months
Clinical Success	Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.	30 days
Clinical Success	Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.	9 months
Hemodynamic Success	Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.	30 days
Hemodynamic Success	Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.	9 months
All Cause Mortality	Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.	30 days
All Cause Mortality	Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.	9 months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: William Gray, MD, NY Presbyterian Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: September 15, 2008
• First Submitted That Met QC Criteria: September 15, 2008
• First Posted (ESTIMATE): September 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt
• Other Study ID Numbers: IP085