Coronary Artery DiseasePhase 2/3DOMINONCT00232791
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
A Phase 2/3 study testing Cypher Select and Cypher in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cypher Select and Cypher
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Mar 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 9Show fewer
- Ejection fraction less than 30%;
- Totally occluded vessel (TIMI 0 level);
- Direct Stenting;
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiothoracic Center Liverpool
Liverpool, L14 3PE
About this study
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.
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cypher Select, Cypher
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cypher SelectDevice
Also called PTCA
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
CypherDevice
Also called PTCA
CYPHER™ Sirolimus-eluting Coronary Stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CYPHER SELECT™ Sirolimus-eluting Coronary Stent Receives: Device: Cypher Select |
| 2 | Active comparator | CYPHER™ Sirolimus-eluting Coronary Stent Receives: Device: Cypher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic in-stent late loss
Measured: 6 months
Secondary outcomes (7)
In-stent mean percent diameter stenosis
Measured: anytime post-procedure
In-target vessel segment MLD
Measured: 6 months
In-stent MLD
Measured: 6 months
Target Lesion Revascularization (TLR)
Measured: 6 months
Target Vessel Revascularization (TVR)
Measured: 6 months
Major Adverse Cardiac Events (MACE)
Measured: 30 days, 6 and 12 months
In-stent volume of restenosis determined by IVUS
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2005 (estimated)
- Study startJan 2004
- Primary completionAug 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R. H. Stables, MD, Principal investigator, Cardiothoracic Centre Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232791
- Sponsor's protocol ID
- EC03-04
- Acronym
- DOMINO
- Status last verified
- Aug 2008
- First submitted
- 4 Oct 2005
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00232791
- Acronym / sponsor ID
- DOMINO / EC03-04
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Cypher SelectCYPHER SELECT™ Sirolimus-eluting Coronary Stent |
| 2 | Active comparator | Device: CypherCYPHER™ Sirolimus-eluting Coronary Stent |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cypher SelectAlso: PTCACYPHER SELECT™ Sirolimus-eluting Coronary Stent | Device | 1 |
| CypherAlso: PTCACYPHER™ Sirolimus-eluting Coronary Stent | Device | 2 |
Primary outcome
Angiographic in-stent late loss
Time frame: 6 months
7 secondary outcomes
In-stent mean percent diameter stenosis
Time frame: anytime post-procedure
In-target vessel segment MLD
Time frame: 6 months
In-stent MLD
Time frame: 6 months
Target Lesion Revascularization (TLR)
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 6 months
Major Adverse Cardiac Events (MACE)
Time frame: 30 days, 6 and 12 months
In-stent volume of restenosis determined by IVUS
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. H. Stables, MD principal investigator
Cardiothoracic Centre Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cypher Select and Cypher in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic in-stent late loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.