Clinical trial NCT00753337: The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 9 months
Secondary outcomes:
measure: Primary Patency Rate at 9 Months
timeFrame: 9 months
measure: Device Success
timeFrame: 9 months
measure: Lesion Success
timeFrame: 9 months
measure: Procedure Success
timeFrame: 9 months
measure: Clinical Success
timeFrame: 30 days
measure: Clinical Success
timeFrame: 9 months
measure: Hemodynamic Success
timeFrame: 30 days
measure: Hemodynamic Success
timeFrame: 9 months
measure: All Cause Mortality
timeFrame: 30 days
measure: All Cause Mortality
timeFrame: 9 months
Other outcomes:
Locations:
city: Flint
country: United States
facility: Michigan Vascular Research Center
state: Michigan
city: New York
country: United States
facility: NY Presbyterian Hospital
state: New York
Study officials:
affiliation: Michigan Vascular Research Center
name: Robert G Molnar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NY Presbyterian Hospital
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.