The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
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).
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 Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Peripheral Vascular Disease
Intervention
Assurant® Cobalt Iliac Stent System
Location
Michigan Vascular Research Center
Flint
Michigan
United States
Status
Active, not recruiting
Source
Medtronic Vascular
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00753337
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cobalt Isotopes
Stable cobalt atoms that have the same atomic number as the element cobalt, but differ in atomic weight. Co-59 is a stable cobalt isotope.
Iliac Aneurysm
Abnormal balloon- or sac-like dilatation in the wall of any one of the iliac arteries including the common, the internal, or the external ILIAC ARTERY.
Cobalt Radioisotopes
Unstable isotopes of cobalt that decay or disintegrate emitting radiation. Co atoms with atomic weights of 54-64, except 59, are radioactive cobalt isotopes.
Nicergoline
An ergot derivative that has been used as a cerebral vasodilator and in peripheral vascular disease. It has been suggested to ameliorate cognitive deficits in cerebrovascular disease.
Flunarizine
Flunarizine is a selective calcium entry blocker with calmodulin binding properties and histamine H1 blocking activity. It is effective in the prophylaxis of migraine, occlusive peripheral vascular disease, vertigo of central and peripheral origin, and as an adjuvant in the therapy of epilepsy.
Clinical Trials
The Complete® Self-Expanding Stent and Stent Delivery System Registry
The purpose of this study is to show if a new delivery system with a modified stent is safe in treating occluded iliac arteries in patients with peripheral vascular disease. The modified C...
Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)
The purpose of this study is to determine the safety and effectiveness of the Scuba™ stent in subjects with symptomatic claudication or rest pain and angiographic confirmation of de novo...
Evaluation of the Zilver Vascular Stent in the Iliac Arteries (ZIPS)
The purpose of this study is to assess the ability of a vascular stent to maintain an open iliac (leg) artery. The Zilver Vascular Stent is made of nitinol, a flexible metal with a long h...
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atheros...
The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System fo...
PubMed Articles
Use of the AorfixTM stent graft in patients with tortuous iliac anatomy.
AIM: Iliac limb occlusion following endovascular repair (EVAR) may result in limb threatening acute ischemia. The incidence is reported at up to 10% and is known to be influenced by iliac angulation a...
Common iliac artery (CIA) aneurysms that extend into the iliac bifurcation and internal iliac artery (IIA) usually require exclusion of the IIA, exposing pelvic ischemic complication risks. This case...
Two-year Clinical Evaluation of the Zilver Vascular Stent for Symptomatic Iliac Artery Disease.
PURPOSE:: To evaluate the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examine the effects of placement in the common iliac artery (CIA) and external iliac artery (...
PURPOSE: To evaluate the efficacy of iliac artery stent placement for relief of claudication in patients with both iliac and superficial femoral artery (SFA) lesions. METHODS: Stent placement for only...
Isolated iliac aneurysm is rare and difficult for surgery repair because it locates in the deep pelvis. Endovascular repair is preferred currently, and internal iliac artery is generally embolized in...
