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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Assurant® Cobalt Iliac Stent System


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assurant Cobalt Iliac Stent<br>Assurant® Cobalt Iliac Stent System | Device: Assurant® Cobalt Iliac Stent System<br>* Iliac Stenting<br>|

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 |