Coronary Artery DiseasePhase 3NCT00231283
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
A Phase 3 study testing CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female patients 18 years of age
- 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) OR patients with documented silent ischemia;
- Treatment of a single de novo target lesion in a major native coronary artery;
- Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
- Target lesion is 30mm in length (visual estimate);
- Target lesion stenosis is > 50% and < 100% (visual estimate);
Who cannot join
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
- Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- Documented Left ventricular ejection fraction 25%;
- Totally occluded vessel (TIMI 0 level);
- Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- 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 NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)Device
CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System Receives: Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
Measured: From post-procedure up to hospital discharge
Secondary outcomes (3)
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Measured: From post-procedure up to 30 days
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Measured: From post-procedure up to hospital discharge
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).
Measured: From post-procedure up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startApr 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emerson Perin, MD, Principal investigator, Texas Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231283
- Sponsor's protocol ID
- P04-6324
- Status last verified
- Apr 2010
- First submitted
- 30 Sep 2005
- Last updated
- 20 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Randomized Study of the CYPHER NxT Sirolimus-Eluting Coronary Stent on BX SONIC OVER-THE-WIRE (OTW) Stent Delivery System(SDS)for the Treatment of de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT00231283
- Acronym / sponsor ID
- P04-6324
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Posted 23 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female patients 18 years of age
- 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) OR patients with documented silent ischemia;
- Treatment of a single de novo target lesion in a major native coronary artery;
- Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
- Target lesion is 30mm in length (visual estimate);
Key exclusion criteria (6 listed)
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
- Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- Documented Left ventricular ejection fraction 25%;
- Totally occluded vessel (TIMI 0 level);
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 NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System | Device | 1 |
Primary outcome
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge
Time frame: From post-procedure up to hospital discharge
Procedure Success is defined as the final residual diameter stenosis < 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
3 secondary outcomes
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later
Time frame: From post-procedure up to 30 days
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge
Time frame: From post-procedure up to hospital discharge
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later
Time frame: From post-procedure up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emerson Perin, MD principal investigator
Texas Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS) in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in United States.
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 6 inclusion and 6 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 20 Apr 2010. 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 States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 23 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge (time frame: From post-procedure up to hospital discharge). 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 20 Apr 2010.