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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232791
First received: October 4, 2005
Last updated: August 5, 2008
Last verified: August 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
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

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:

  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;
  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on September 30, 2014