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PRESILLION cobalt chromium stent

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Jun 14, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

PRESILLION cobalt chromium stent · 1 trial · 1 indication

Phase 3 1
NCT00722579A Study of the Presillion Stent in de Novo Coronary LesionsCoronary Artery Disease
COMPLETED101 Analytics
PHASE3COMPLETED
A Study of the Presillion Stent in de Novo Coronary Lesions
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Composite of MACE which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR).
1-month and 6-months post-procedure

Secondary Endpoints

Clinically driven Target Lesion Revascularization (TLR) defined as repeat PCI or CABG to the target lesion.
1-month and 6-months post-procedure
Clinically driven Target Vessel Revascularization (TVR) defined as repeat PCI or CABG to the target vessel.
1-month and 6-months post-procedure
Target Vessel Failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
1-month and 6-months post-procedure
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALThe PRESILLION TM Coronary Stent is an L-605 cobalt chromium (CoCr) stent.

Interventions

NameTypeDescription
PRESILLION cobalt chromium stentDEVICEPTCA with bare-metal stent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * The patient must be \>= 18 years of age. * Patient is eligible for percutaneous coronary intervention (PCI). * Acceptable candidate for coronary artery bypass surgery (CABG). * Female patients of childbearing potential must have a negative pregnancy test within 7 days prior to...

Countries:Belgium
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Frequently asked questions about PRESILLION cobalt chromium stent

What is the PRESILLION cobalt chromium stent used for?

The PRESILLION cobalt chromium stent is used for treating Coronary Artery Disease. It is a coronary stent designed to be implanted in de novo coronary lesions. The device is currently in clinical development and is not yet approved for commercial use.

Who makes the PRESILLION cobalt chromium stent?

The PRESILLION cobalt chromium stent is developed by Cardinal Health, Inc., which trades under the ticker CAH. The company is conducting clinical trials to evaluate the safety and effectiveness of this coronary stent for patients with Coronary Artery Disease.

What phase is the PRESILLION cobalt chromium stent in?

The PRESILLION cobalt chromium stent is in Phase 3 clinical development. It is an investigational device, meaning it has not yet received regulatory approval. One Phase 3 trial has been completed, and the device is not currently in active clinical trials.

What clinical trials is the PRESILLION cobalt chromium stent in?

The PRESILLION cobalt chromium stent has been studied in one completed Phase 3 trial, NCT00722579, titled 'A Study of the Presillion Stent in de Novo Coronary Lesions.' This trial enrolled 101 participants with Coronary Artery Disease and was conducted in Belgium.

Is the PRESILLION cobalt chromium stent the same as the Presillion stent?

Yes, the PRESILLION cobalt chromium stent is the same as the Presillion stent. The clinical trial NCT00722579 refers to it as the 'Presillion Stent,' and the full product name includes 'cobalt chromium' to describe the stent material. Both names refer to the same investigational device.