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drug eluting-stent, drug-eluting stent

Phase 3

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Sep 16, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment1,508

FDA Designations

No designations recorded

Clinical trial landscape

drug eluting-stent, drug-eluting stent · 4 trials · 1 indication

Phase 3 3Phase 2 1
NCT00232830The Study to Assess AMI Treated With Balloon Angioplasty.Coronary Artery Disease
COMPLETED715 Analytics
NCT00235170The Arterial Revascularization Therapies Study Part II.Coronary Artery Disease
COMPLETED607 Analytics
NCT00381420The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.Coronary Artery Disease
COMPLETED100 Analytics
PHASE3COMPLETED
The Study to Assess AMI Treated With Balloon Angioplasty.
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
The Arterial Revascularization Therapies Study Part II.
Coronary Artery DiseaseUnlock trial analytics
PHASE3COMPLETED
The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Composite of 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 vesselpost-procedure.
1 and 6 months and at 1, 3, 4, and 5 years post-procedure.
abscence of major adverse cardiac and cerebral vascular events (MACCE)
1 year
in-stent minimum lumen diameter (MLD)
8 months
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
6-months post-procedure

Secondary Endpoints

cardiac death
1, 3, 4 and 5 years post-procedure
recurrence of myocardial infarction
1, 3, 4 and 5 years post-procedure
revascularization of the target vessel (TVR)
1, 3, 4 and 5 years post-procedure
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCypher Sirolimus-eluting Coronary Stent
2ACTIVE_COMPARATORBare-metal stent

Interventions

NameTypeDescription
drug-eluting stentDEVICECypher Sirolimus-eluting Coronary Stent
bare-metal stentDEVICEany bare-metal stent brand
drug eluting-stentDEVICEPCI
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following: 1. ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial lead...

Countries:FranceGermanyNetherlandsItaly
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Frequently asked questions about drug eluting-stent, drug-eluting stent

What is the drug-eluting stent used for?

The drug-eluting stent is used to treat coronary artery disease and peripheral artery disease. It is a stent designed to release medication to help keep arteries open. Clinical studies have evaluated it in patients with conditions such as coronary artery disease and peripheral artery disease, including those with de novo artery lesions and bifurcation lesions.

Who makes the drug-eluting stent?

Cardinal Health, Inc. (NYSE: CAH) is the developer of the drug-eluting stent. The company has sponsored clinical trials of the stent for treating coronary artery disease and peripheral artery disease. These trials have been conducted in multiple countries, including France, Germany, and Italy.

What phase is the drug-eluting stent in?

The drug-eluting stent is in Phase 3 clinical development for coronary artery disease and peripheral artery disease. It has completed four clinical trials, including Phase 3 studies. The stent is investigational and not yet approved for commercial use based on the available clinical trial data.

What clinical trials is the drug-eluting stent in?

The drug-eluting stent has completed four clinical trials. NCT00232830 is a Phase 3 study in coronary artery disease with 715 participants. NCT00232869 is a Phase 2 study in peripheral artery disease with 93 participants. NCT00234455 is a Phase 2 study in coronary artery disease with 86 participants. NCT00381420 is a Phase 3 study in coronary artery disease with 100 participants.

Is the drug-eluting stent the same as the Cypher sirolimus-eluting stent?

The drug-eluting stent is evaluated in clinical trials under different names, including the Cypher sirolimus-eluting stent and the BX Velocity stent. One completed study, NCT00234455, specifically investigated the Cypher sirolimus-eluting stent for treating bifurcation lesions in coronary artery disease. Another study, NCT00381420, examined the BX Velocity stent for de novo artery lesions.

What conditions does the drug-eluting stent treat?

The drug-eluting stent treats coronary artery disease and peripheral artery disease. Clinical trials have enrolled patients with these conditions, including those with acute myocardial infarction, superficial femoral artery disease, bifurcation lesions, and de novo artery lesions. The studies were randomized, double-blind, and controlled, with a total enrollment of 1,508 participants across all trials.