The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

Coronary Artery Disease Clinical Trial

— DOMINO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232791
• Other study ID #: EC03-04
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 4, 2005
• Last updated: August 5, 2008
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: August 2008
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2005
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 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;

3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);

4. 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;

5. Target lesion stenosis is > 50% and < 100% (visual estimate).

Exclusion Criteria:

1. 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;

2. Unprotected left main coronary disease with more than 50% stenosis;

3. Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;

4. Have an ostial target lesion;

5. Angiographic evidence of thrombus within target lesion;

6. Calcified lesions which cannot be successfully predilated;

7. Ejection fraction less than 30%;

8. Totally occluded vessel (TIMI 0 level);

9. Direct Stenting;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Cypher Select
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
• Cypher
CYPHER™ Sirolimus-eluting Coronary Stent

Locations

Country	Name	City	State
United Kingdom	Cardiothoracic Center Liverpool	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-stent late loss		6 months	Yes
Secondary	In-stent mean percent diameter stenosis		anytime post-procedure	Yes
Secondary	In-target vessel segment MLD		6 months	Yes
Secondary	In-stent MLD		6 months	Yes
Secondary	Target Lesion Revascularization (TLR)		6 months	Yes
Secondary	Target Vessel Revascularization (TVR)		6 months	Yes
Secondary	Major Adverse Cardiac Events (MACE)		30 days, 6 and 12 months	Yes
Secondary	In-stent volume of restenosis determined by IVUS		6 months	Yes