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

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Cypher Select; Device: Cypher

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; CYPHER SELECT™ Sirolimus-eluting Coronary Stent	Device: Cypher Select; CYPHER SELECT™ Sirolimus-eluting Coronary Stent; Other Names: PTCA
Active Comparator: 2; CYPHER™ Sirolimus-eluting Coronary Stent	Device: Cypher; CYPHER™ Sirolimus-eluting Coronary Stent; Other Names: PTCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Angiographic in-stent late loss	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: R. H. Stables, MD, Cardiothoracic Centre Liverpool

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): August 1, 2004
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Estimate): August 6, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: EC03-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No