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

2014-08-27 03:28:31 | 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

Published on BioPortfolio: 2014-08-27T03:28:31-0400

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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...

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VISIBILITY™ Iliac Study

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PubMed Articles [7476 Associated PubMed Articles listed on BioPortfolio]

Design and Comparison of Large Vessel Stents: Balloon Expandable and Self-Expanding Peripheral Arterial Stents.

Endovascular stenting has evolved over the last 50 years since its inception into the framework of management of vascular atherosclerotic disease. Stent design has evolved as lesion complexity has in...

Open surgical removal of iliac vein Wallstents with excision of pseudointima obstructing the contralateral iliac vein.

Persistent pain after iliac vein stenting is rare. Surgical removal of two oversized (20-mm) iliac vein stents was performed in a 36-year-old woman because of severe back pain of 2½ years' duration. ...

Patency and limb salvage after femoral endarterectomy and iliac stenting are not affected by severity of iliac disease.

The hybrid procedure of femoral endarterectomy and iliac artery stenting (FEIS) has been used as an alternative to traditional open surgical repair of iliofemoral arterial occlusive disease, but wheth...

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Bilateral common iliac artery (CIA) aneurysm (CIAA) is a rare entity. In the past decade, different endovascular approaches have been adopted for patients with several comorbidities or unfit for open ...

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Medical and Biotech [MESH] Definitions

A compression of ILIAC VEIN that results in a decreased flow in the vein and in the left LOWER EXTREMITY due to a vascular malformation. It may result in left leg EDEMA, pain, iliofemoral DEEP VENOUS THROMBOSIS and POSTTHROMBOTIC SYNDROME. Compression of the left common ILIAC VEIN by the right common ILIAC ARTERY against the underlying fifth LUMBAR VERTEBRA is the typical underlying malformation.

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.

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