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The Complete® Self-Expanding Stent and Stent Delivery System Registry

23:45 EDT 24th July 2014 | BioPortfolio

Summary

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 Complete SE delivery system is hypothesized to assist physicians with more accurate stent placement reducing the likelihood of stent 'jumping' seen with the use of many self-expanding stent systems.

Description

The study is being conducted to collect the 30-day safety data on the stent delivery system for all subjects enrolled into the study (with a minimum of 50 subjects enrolled) as well as the long-term 9-month safety and efficacy data on all subjects enrolled (with a minimum of 10 subjects enrolled into the study having the 120mm length stent implanted).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peripheral Vascular Disease

Intervention

Iliac stenting (Complete® Self-Expanding Stent )

Location

Michigan Vascular Research Center
Flint
Michigan
United States
48507

Status

Active, not recruiting

Source

Medtronic Vascular

Results (where available)

View Results

Links

Clinical Trials [1096 Associated Clinical Trials listed on BioPortfolio]

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...

Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System and Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Ilia

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...

PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal...

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

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 subject...

VISIBILITY™ Iliac Study

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 [8589 Associated PubMed Articles listed on BioPortfolio]

Endovascular Repair of Abdominal Aortic Aneurysm using Bifurcated Stent-graft in a Patient with Complete Occlusion from the Common to the External Iliac Artery.

Extensive iliofemoral occlusive disease can limit the use of endovascular aortic aneurysm repair (EVAR), and the treatment strategy varies depending on severity of the lesion. In cases of mild iliac a...

A case of iliac artery injury treated by covered stent during carotid artery stenting.

Here we describe a case of iliac artery injury during carotid artery stenting (CAS) treated by covered stent. A 74-year-old man underwent CAS for asymptomatic right carotid artery stenosis. Under loca...

Effect of atorvastatin-eluting stents in a rabbit iliac artery restenosis model.

Statins have pleiotropic effects, which include the inhibition of neointima hyperplasia, the inhibition of vascular inflammation, and platelet inhibition. The aim of this study was to examine the effe...

Results of endoprosthetic reconstruction in patients with aneurysm of the infrarenal portion of the aorta.

The authors herein share their experience with implantation of endografts in a total of 41 patients for an aneurysm of the infrarenal portion of the aorta. Of these, there were 34 (83%) men and 7 (17%...

Management of Recurrent Iliac Artery Stenosis in Individuals Aged 55 or Less.

Aortoiliac disease is the most common location for symptomatic peripheral arterial disease in young patients. Angioplasty with stenting has become the initial treatment of choice for most patients. Ho...

Medical and Biotech [MESH] Definitions

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.

A peripheral vasodilator that was formerly used in the management of peripheral and cerebral vascular disorders. It is hepatotoxic and fatalities have occurred. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1312)

Obstruction of the flow in the SPLANCHNIC CIRCULATION by ATHEROSCLEROSIS; EMBOLISM; THROMBOSIS; STENOSIS; TRAUMA; and compression or intrinsic pressure from adjacent tumors. Rare causes are drugs, intestinal parasites, and vascular immunoinflammatory diseases such as PERIARTERITIS NODOSA and THROMBOANGIITIS OBLITERANS. (From Juergens et al., Peripheral Vascular Diseases, 5th ed, pp295-6)

The vascular resistance to the flow of BLOOD through the CAPILLARIES portions of the peripheral vascular bed.

A vein on either side of the body which is formed by the union of the external and internal iliac veins and passes upward to join with its fellow of the opposite side to form the inferior vena cava.

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