Coronary Artery DiseasePhase 4CACTUSNCT00749424
The Study of the Crushing Technique Application Using SES in Coronary Bifurcations.
A Phase 4 study testing SES 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 compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the "crushing" technique to stent both branches vs. 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?
- SES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Apr 2009
- Phase
- Phase 4
- 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
- Is a male or non-pregnant female patient >= 18 years of age [NOTE: Females of child-bearing potential must have a negative pregnancy test];
- 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;
- Has at least TIMI I coronary flow in both the main and side branches;
- 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 maximum treatable main or side branch lesion length <=28 mm;
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- 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 >= 2.25 mm and <= 3.5 mm in diameter by on-line QCA;
- Is an acceptable candidate for coronary artery bypass surgery (CABG);
- Is willing to comply with the specified follow-up evaluation;
- The patient or legally authorized representative must provide written informed consent prior to the procedure.
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, B\&C III;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction <= 35%;
- Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
- Has a known serious allergy to contrast media or stainless steel that cannot be managed medically;
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- Has impaired renal function (creatinine > 3.0 mg/dl);
- There is presence of thrombus in the bifurcation lesion;
- Has a target lesion with excessive tortuousity unsuitable for stent delivery and deployment;
- Has a totally occluded vessel;
- Is the recipient of a heart transplant;
- Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Is currently participating in an investigational drug or another device study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CORONARY BIFURCATIONS: APPLICATION OF THE CRUSHING TECHNIQUE USING SIROLIMUS-ELUTING STENTS - The "CACTUS" Trial
The objective of this study is to compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the "crushing" technique to stent both branches vs. b) a provisional T stenting technique of the side branch.
Read the detailed description
This is a prospective, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be treated with the Cypher SelectTM Stent and Stent Delivery System (SDS). Patients will have repeat angiography at six months, with clinical follow-up to 2 years.
- Conditions
- Coronary Artery Disease
- Being tested
- SES
- 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.
SESDevice
CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
SESDevice
CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | crushing technique Receives: Device: SES |
| 2 | Active comparator | provisional T stenting technique Receives: Device: SES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse and Cardiac Events (MACE)
Measured: 6 and 12 months post-procedure
Secondary outcomes (2)
Minimal lumen diameter (MLD)
Measured: 6 months
Percent diameter stenosis (%DS)
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 posted9 Sep 2008 (estimated)
- Study startJan 2004
- Primary completionMay 2005
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Antonio Colombo, MD, PhD, Principal investigator, Fondazione Centro San Raffaele del Monte Tabor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749424
- Sponsor's protocol ID
- CRDIT 00-01/03
- Acronym
- CACTUS
- Status last verified
- Feb 2010
- First submitted
- 8 Sep 2008
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22.
PubMed 19103990
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORONARY BIFURCATIONS: APPLICATION OF THE CRUSHING TECHNIQUE USING SIROLIMUS-ELUTING STENTS - The "CACTUS" Trial
- ClinicalTrials.gov ID
- NCT00749424
- Acronym / sponsor ID
- CACTUS / CRDIT 00-01/03
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 9 Sep 2008 (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 compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the "crushing" technique to stent both branches vs. b) a provisional T stenting technique of the side branch.
Detailed description
This is a prospective, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be treated with the Cypher SelectTM Stent and Stent Delivery System (SDS). Patients will have repeat angiography at six months, with clinical follow-up to 2 years.
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: SEScrushing technique |
| 2 | Active comparator | Device: SESprovisional T stenting technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is a male or non-pregnant female patient >= 18 years of age [NOTE: Females of child-bearing potential must have a negative pregnancy test];
- 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;
- Has at least TIMI I coronary flow in both the main and side branches;
- 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;
Key exclusion criteria (13 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, B\&C III;
- Has a bifurcation lesion in a non protected left main;
- Has an ejection fraction <= 35%;
- Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
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 |
|---|---|---|
| SESCYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent | Device | 1 |
| SESCYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent | Device | 2 |
Primary outcome
Major Adverse and Cardiac Events (MACE)
Time frame: 6 and 12 months post-procedure
2 secondary outcomes
Minimal lumen diameter (MLD)
Time frame: 6 months
Percent diameter stenosis (%DS)
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 4 Feb 2010.
- Results publication: PubMed 19103990Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22.
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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, PhD principal investigator
Fondazione Centro San Raffaele del Monte Tabor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SES 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 11 inclusion and 13 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 4 Feb 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Major Adverse and Cardiac Events (MACE) (time frame: 6 and 12 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 NCT00749424, which also lists 1 linked publication.
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 4 Feb 2010.