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

2014-08-26 22:28:31 | BioPortfolio


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.


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


Peripheral Vascular Disease


Iliac stenting (Complete® Self-Expanding Stent )


Michigan Vascular Research Center
United States


Active, not recruiting


Medtronic Vascular

Results (where available)

View Results


Published on BioPortfolio: 2014-08-26T22:28:31-0400

Clinical Trials [1347 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...


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 [7686 Associated PubMed Articles listed on BioPortfolio]

Influence of Iliac Vein Stent Implantation on the Contralateral Iliac Vein.

Stent implantation is frequently used to treat iliac vein occlusion. However, the recommended extension of the stent mesh into the inferior vena cava (IVC) may affect blood flow through the contralate...

Angioplasty versus stenting for iliac artery lesions.

Atherosclerosis of the iliac artery may result in a stenosis or occlusion, which is defined as iliac artery occlusive disease. A range of surgical and endovascular treatment options are available. Ope...

Should We Routinely Stent the Femoropopliteal Artery? An Interventionalist's Perspective.

Stenting of femoropopliteal (FP) arterial disease is currently the most common strategy adopted by endovascular specialists. Several randomized trials have shown that stenting with nitinol self-expand...

The effect of demographic factors and lesion severity on iliac stent patency.

The aim of our study was to perform a large multivariate analysis to identify demographic, anatomic, or procedural factors that affect iliac artery stent primary patency (PP).

Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions.

This study compared early and midterm outcomes of polytetrafluoroethylene-covered stents (CSs) vs bare-metal stents (BMSs) in the primary treatment of severe TransAtlantic Inter-Society Consensus for ...

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.

More From BioPortfolio on "The Complete® Self-Expanding Stent and Stent Delivery System Registry"


Relevant Topics

A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Searches Linking to this Trial