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Cypher Select, Cypher

Phase 2

Coronary Artery Disease | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Aug 6, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Cypher Select, Cypher · 1 trial · 1 indication

Phase 2 1
NCT00232791The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.Coronary Artery Disease
COMPLETED102 Analytics
PHASE2COMPLETED
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Angiographic in-stent late loss
6 months

Secondary Endpoints

In-stent mean percent diameter stenosis
anytime post-procedure
In-target vessel segment MLD
6 months
In-stent MLD
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCYPHER SELECT™ Sirolimus-eluting Coronary Stent
2ACTIVE_COMPARATORCYPHER™ Sirolimus-eluting Coronary Stent

Interventions

NameTypeDescription
Cypher SelectDEVICECYPHER SELECT™ Sirolimus-eluting Coronary Stent
CypherDEVICECYPHER™ Sirolimus-eluting Coronary Stent
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia; 2. Single treatment of de novo lesion in a coronar...

Countries:United Kingdom
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Frequently asked questions about Cypher Select, Cypher

What is Cypher Select used for?

Cypher Select is used for treating coronary artery disease, specifically coronary artery lesions. It is an investigational drug-device combination being studied in patients with this condition. The product is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Cypher Select?

Cypher Select is being developed by Cardinal Health, Inc., which trades under the ticker CAH. The company is conducting clinical research on this product for the treatment of coronary artery disease. The product is currently in Phase 2 development.

What phase is Cypher Select in?

Cypher Select is in Phase 2 clinical development. It is an investigational product for coronary artery disease and is not yet approved. One Phase 2 trial has been completed, involving 102 participants in the United Kingdom.

What clinical trials is Cypher Select in?

Cypher Select has one completed Phase 2 clinical trial, NCT00232791, titled "The Study to Compare Cypher Versus Cypher Select in Treating Coronary Artery Lesions." This active-controlled, randomized study enrolled 102 patients with coronary artery disease in the United Kingdom.

Is Cypher Select the same as Cypher?

Cypher Select is a distinct product being compared against Cypher in clinical trials. The completed Phase 2 study, NCT00232791, directly compared Cypher versus Cypher Select in treating coronary artery lesions, indicating they are separate treatments under evaluation.