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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cypher Select
Cypher
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Cardiothoracic Center Liverpool

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

CYPHER™ Sirolimus-eluting Coronary Stent

Outcomes

Primary Outcome Measures

Angiographic in-stent late loss

Secondary Outcome Measures

In-stent mean percent diameter stenosis
In-target vessel segment MLD
In-stent MLD
Target Lesion Revascularization (TLR)
Target Vessel Revascularization (TVR)
Major Adverse Cardiac Events (MACE)
In-stent volume of restenosis determined by IVUS

Full Information

First Posted
October 4, 2005
Last Updated
August 5, 2008
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00232791
Brief Title
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Arm Title
2
Arm Type
Active Comparator
Arm Description
CYPHER™ Sirolimus-eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
Cypher Select
Other Intervention Name(s)
PTCA
Intervention Description
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
Cypher
Other Intervention Name(s)
PTCA
Intervention Description
CYPHER™ Sirolimus-eluting Coronary Stent
Primary Outcome Measure Information:
Title
Angiographic in-stent late loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
In-stent mean percent diameter stenosis
Time Frame
anytime post-procedure
Title
In-target vessel segment MLD
Time Frame
6 months
Title
In-stent MLD
Time Frame
6 months
Title
Target Lesion Revascularization (TLR)
Time Frame
6 months
Title
Target Vessel Revascularization (TVR)
Time Frame
6 months
Title
Major Adverse Cardiac Events (MACE)
Time Frame
30 days, 6 and 12 months
Title
In-stent volume of restenosis determined by IVUS
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. H. Stables, MD
Organizational Affiliation
Cardiothoracic Centre Liverpool
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic Center Liverpool
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom

12. IPD Sharing Statement

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

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