Coronary Artery DiseasePhase 3NCT00232752

Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

A Phase 3 study testing 4.0 CYPHER Sirolimus-Eluting Coronary Stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss 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?: 4.0 CYPHER Sirolimus-Eluting Coronary Stent
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: Sep 2003to Nov 2009
Phase: Phase 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or non-pregnant female patients minimum 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;
Target lesions treatable with 4mm stent (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 remains above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
Documented Left ventricular ejection fraction 25%;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham & Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Conditions: Coronary Artery Disease
Being tested: 4.0 CYPHER Sirolimus-Eluting Coronary Stent
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.

4.0 CYPHER Sirolimus-Eluting Coronary StentDevice
4.0 CYPHER Sirolimus-Eluting Coronary Stent

Study groups in NCT00232752
Study group	Role	What they receive
1	Experimental	Not described Receives: Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Measured: 6 months post-procedure

Secondary outcomes (10)

Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced
Measured: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure
Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
Measured: 6 months post-procedure
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
Measured: 6 months post-procedure
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
Measured: 6 and 9 months post-procedure
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
Measured: 6 and 9 months post-procedure
Target vessel failure (TVF) at 6 and 9 months post-procedure.
Measured: 6 and 9 months post-procedure
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.
Measured: post-procedure and six months in a subset of approximately 50 patients
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Measured: End of study
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Measured: End of Study
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.
Measured: during the hospital stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Nov 2009

First posted5 Oct 2005 (estimated)
Study startSep 2003
Primary completionJan 2005
Study completionNov 2009

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00232752
Sponsor's protocol ID: P03-6319
Status last verified: Dec 2009
First submitted: 3 Oct 2005
Last updated: 2 Dec 2009
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
ClinicalTrials.gov ID: NCT00232752
Acronym / sponsor ID: P03-6319
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: Sep 2003
Primary completion: Jan 2005 (actual)
Study completion: Nov 2009 (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.

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: 4.0 CYPHER Sirolimus-Eluting Coronary Stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or non-pregnant female patients minimum 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;
Target lesions treatable with 4mm stent (visual estimate);
Target lesion is 30mm in length (visual estimate);
Target lesion stenosis is >50% and <100% (visual estimate);

Key exclusion criteria (4 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 remains above normal at the time of treatment;
Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
Documented Left ventricular ejection fraction 25%;
Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

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
4.0 CYPHER Sirolimus-Eluting Coronary Stent4.0 CYPHER Sirolimus-Eluting Coronary Stent	Device	1

Primary outcome

The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
Time frame: 6 months post-procedure

10 secondary outcomes

Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced
Time frame: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure
Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
Time frame: 6 months post-procedure
In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
Time frame: 6 months post-procedure
Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
Time frame: 6 and 9 months post-procedure
Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
Time frame: 6 and 9 months post-procedure
Target vessel failure (TVF) at 6 and 9 months post-procedure.
Time frame: 6 and 9 months post-procedure
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers.
Time frame: post-procedure and six months in a subset of approximately 50 patients
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.
Time frame: End of study
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
Time frame: End of Study
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay.
Time frame: during the hospital stay

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 2 Dec 2009.

Related trials for Coronary Artery Disease

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Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
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Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
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RecruitingObservational study
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Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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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.

Mauri Laura, MD principal investigator

Brigham and Women's Hospital

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 4.0 CYPHER Sirolimus-Eluting Coronary Stent 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 5 inclusion and 4 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 2 Dec 2009. 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?

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?

The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00232752.

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 2 Dec 2009.