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The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

2014-07-23 21:46:16 | BioPortfolio

Summary

To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Description

This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Study Design

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

Conditions

Aneurysms

Intervention

Cordis Self Expanding Stent

Location

Azienda Ospedaliera
Milano
Italy
20162

Status

Completed

Source

Codman & Shurtleff

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:46:16-0400

Clinical Trials [797 Associated Clinical Trials listed on BioPortfolio]

Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm) i...

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...

Continuous Infra-Inguinal Stenting Using the FlexStar and FlexStar XL Ultra Long Metallic Self-Expanding Stent Systems

To collect both pre-market and post-market confirmatory evidence of the safety and effectiveness of the LifeStent Self-Expanding Stent System in patients with de novo and restenotic (non-s...

PubMed Articles [1312 Associated PubMed Articles listed on BioPortfolio]

The Use of Single Stent-Assisted Coiling in Treatment of Bifurcation Aneurysms: A Multicenter Cohort Study With Proposal of a Scoring System to Predict Complete Occlusion.

The development of stent-assisted coiling has allowed for the endovascular treatment of wide-necked bifurcation aneurysms. A variety of options exist, and little is known about the optimal stent confi...

Long term follow-up of bifurcation aneurysms treated with braided stent assisted coiling and complex T- and Y- stent constructs.

Stent assisted coil embolization (SACE) of bifurcation aneurysms is challenging. Heterogeneous results have been achieved to date, but largely for laser cut stents. While braided stents offer multiple...

Comparison of Stent-Assisted Coil Placement and Coiling-Only for the Treatment of Ruptured Intracranial Aneurysms.

BACKGROUND The use of a stent during the acute post-hemorrhage period is controversial. We conducted a retrospective analysis on the clinical and angiographic outcomes of the ruptured aneurysms that w...

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...

Modification of hemodynamics in basilar artery aneurysm by the single and Y stent placement1.

Stent placement can change the hemodynamics in basilar artery aneurysms. However, the effects of the stent placement can depend on the angle of vessel bifurcation.

Medical and Biotech [MESH] Definitions

A sudden CARDIAC ARRHYTHMIA (e.g., VENTRICULAR FIBRILLATION) caused by a blunt, non-penetrating impact to the precordial region of chest wall. Commotio cordis often results in sudden death without prompt cardiopulmonary defibrillation.

A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.

A localized bulging or dilatation in the muscle wall of a heart (MYOCARDIUM), usually in the LEFT VENTRICLE. Blood-filled aneurysms are dangerous because they may burst. Fibrous aneurysms interfere with the heart function through the loss of contractility. True aneurysm is bound by the vessel wall or cardiac wall. False aneurysms are HEMATOMA caused by myocardial rupture.

Aneurysm of the MICROVASCULATURE. Charcot–Bouchard aneurysms are aneurysms of the brain vasculature which is a common cause of CEREBRAL HEMORRHAGE. Retinal microaneurysm is an early diagnostic sign of DIABETIC RETINOPATHY.

Abnormal outpouching in the wall of intracranial blood vessels. Most common are the saccular (berry) aneurysms located at branch points in CIRCLE OF WILLIS at the base of the brain. Vessel rupture results in SUBARACHNOID HEMORRHAGE or INTRACRANIAL HEMORRHAGES. Giant aneurysms (>2.5 cm in diameter) may compress adjacent structures, including the OCULOMOTOR NERVE. (From Adams et al., Principles of Neurology, 6th ed, p841)

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