The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions. - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00232791

Purpose

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Cypher Select Device: Cypher	Phase II Phase III

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Study With the CYPHER SELECT™ Sirolimus-Eluting Balloon-Expandable Coronary Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions.

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

Angiographic in-stent late loss [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

In-stent mean percent diameter stenosis [ Time Frame: anytime post-procedure ] [ Designated as safety issue: Yes ]
In-target vessel segment MLD [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
In-stent MLD [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Target Lesion Revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Target Vessel Revascularization (TVR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days, 6 and 12 months ] [ Designated as safety issue: Yes ]
In-stent volume of restenosis determined by IVUS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	102
Study Start Date:	January 2004
Study Completion Date:	March 2005
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CYPHER SELECT™ Sirolimus-eluting Coronary Stent	Device: Cypher Select CYPHER SELECT™ Sirolimus-eluting Coronary Stent
2: Active Comparator CYPHER™ Sirolimus-eluting Coronary Stent	Device: Cypher CYPHER™ Sirolimus-eluting Coronary Stent

Detailed Description:

This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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;
Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
Target lesion stenosis is > 50% and < 100% (visual estimate).

Exclusion Criteria:

A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
Unprotected left main coronary disease with more than 50% stenosis;
Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Have an ostial target lesion;
Angiographic evidence of thrombus within target lesion;
Calcified lesions which cannot be successfully predilated;
Ejection fraction less than 30%;
Totally occluded vessel (TIMI 0 level);
Direct Stenting;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232791

Locations

United Kingdom
Cardiothoracic Center Liverpool
Liverpool, United Kingdom, L14 3PE

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

R. H. Stables, MD

Cardiothoracic Centre Liverpool

More Information

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll, Director Clinical Affairs )
Study ID Numbers:	EC03-04
Study First Received:	October 4, 2005
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00232791
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009