Coronary Artery DiseasePhase 2BIFURCATIONNCT00234455
A Study of the Cypher Sirolimus-Eluting Stent to Treat Bifurcation Lesions.
A Phase 2 study testing drug eluting-stent and drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Italy.
Trial summary
The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation 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?
- drug eluting-stent and drug-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2001to Apr 2007
- Phase
- Phase 2
- 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
- Has a 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 has documented silent ischemia;
- Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
- Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
- Has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
- Has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA.
Who cannot join
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels > 2 times normal or CK-MB levels > 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction <=35%;
- There is presence of thrombus in the bifurcation lesion;
- Has a totally occluded vessel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.
The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
Read the detailed description
This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.
- Conditions
- Coronary Artery Disease
- Being tested
- drug eluting-stent, drug-eluting 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.
drug eluting-stentDevice
Also called sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
PCI
drug-eluting stentDevice
Also called sirolimus-coated Bx VELOCITY Balloon-Expandable Stent
PCI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group) Receives: Device: drug eluting-stent |
| 2 | Other | stents in both the main and side branches (stent/stent group) Receives: Device: drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
Measured: 6-months post-procedure
Secondary outcomes (4)
device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only
Measured: anytime during the course of the study
procedure success defined as achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay
Measured: anytime during the course of the study
target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization
Measured: 6, 12, 18, and 24 months post-procedure
lumen and obstruction volume by intravascular ultrasound (IVUS)
Measured: 6-month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startJun 2001
- Primary completionOct 2002
- Study completionApr 2007
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio Colombo, MD, Principal investigator, Centre Cuore Columbus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234455
- Sponsor's protocol ID
- EC01-02
- Acronym
- BIFURCATION
- Status last verified
- Apr 2008
- First submitted
- 5 Oct 2005
- Last updated
- 30 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions.
- ClinicalTrials.gov ID
- NCT00234455
- Acronym / sponsor ID
- BIFURCATION / EC01-02
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Oct 2002 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 7 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 objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
Detailed description
This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: drug eluting-stentstent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group) |
| 2 | Other | Device: drug-eluting stentstents in both the main and side branches (stent/stent group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a 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 has documented silent ischemia;
- Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
- Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
- Has a main branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA proximal to the bifurcation;
- Has a side branch vessel that is <=2.5 mm and <=3.5 mm in diameter by on-line QCA.
Key exclusion criteria (6 listed)
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels > 2 times normal or CK-MB levels > 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald A I-III, or III B or C, or is having a peri infarction;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction <=35%;
- There is presence of thrombus in the bifurcation 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 |
|---|---|---|
| drug eluting-stentAlso: sirolimus-coated Bx VELOCITY Balloon-Expandable StentPCI | Device | 1 |
| drug-eluting stentAlso: sirolimus-coated Bx VELOCITY Balloon-Expandable StentPCI | Device | 2 |
Primary outcome
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
Time frame: 6-months post-procedure
4 secondary outcomes
device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only
Time frame: anytime during the course of the study
procedure success defined as achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay
Time frame: anytime during the course of the study
target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization
Time frame: 6, 12, 18, and 24 months post-procedure
lumen and obstruction volume by intravascular ultrasound (IVUS)
Time frame: 6-month post-procedure
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 30 Apr 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.
Antonio Colombo, MD principal investigator
Centre Cuore Columbus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing drug eluting-stent and drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Italy.
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 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 30 Apr 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (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?
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 30 Apr 2008.