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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232791
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : August 6, 2008
Information provided by:
Cordis Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Cypher Select Device: Cypher Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: 1
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Device: Cypher Select
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Other Name: PTCA

Active Comparator: 2
CYPHER™ Sirolimus-eluting Coronary Stent
Device: Cypher
CYPHER™ Sirolimus-eluting Coronary Stent
Other Name: PTCA

Primary Outcome Measures :
  1. Angiographic in-stent late loss [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. In-stent mean percent diameter stenosis [ Time Frame: anytime post-procedure ]
  2. In-target vessel segment MLD [ Time Frame: 6 months ]
  3. In-stent MLD [ Time Frame: 6 months ]
  4. Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
  5. Target Vessel Revascularization (TVR) [ Time Frame: 6 months ]
  6. Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days, 6 and 12 months ]
  7. In-stent volume of restenosis determined by IVUS [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232791

United Kingdom
Cardiothoracic Center Liverpool
Liverpool, United Kingdom, L14 3PE
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: R. H. Stables, MD Cardiothoracic Centre Liverpool

Responsible Party: Dr. Hans-Peter Stoll, Director Clinical Affairs, Cordis Identifier: NCT00232791     History of Changes
Other Study ID Numbers: EC03-04
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs