Coronary Artery DiseasePhase 4TROPICALNCT00232856
A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.
A Phase 4 study testing drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites in 2 countries.
Trial summary
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2002to Aug 2006
- 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
- The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
- The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.
Who cannot join
- Unprotected left main coronary disease with ≥ 50% stenosis;
- Patient previously treated with brachytherapy in any coronary vessel.
- Target lesion involves bifurcation including a side branch >2.5mm in diameter.
- The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
Read the detailed description
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
- Conditions
- Coronary Artery Disease
- Being tested
- 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 Cypher™ sirolimus-eluting stent
PCI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Cypher™ sirolimus-eluting stent Receives: Device: drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic in-lesion late loss
Measured: 6 months post-procedure
Secondary outcomes (7)
in-stent mean percent diameter stenosis (%DS)
Measured: 6-months post-procedure
i-stent late loss (LL)
Measured: 6 months post-procedure
in-lesion binary restenosis
Measured: 6-months post-procedure
Target Vessel Revascularization (TVR)
Measured: 9-months post-procedure
Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel
Measured: 9 months post-procedure
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 in-hospital
Measured: 1, 6, 9 months and, 2 and 3 years post-procedure
occurrence of bleeding
Measured: 1, 6, 9 months and, 2 and 3 years post-procedure
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 startDec 2002
- Primary completionDec 2003
- Study completionAug 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Franz-Josef Neumann, MD, Principal investigator, Herz-zentrum Bad KrozingenWalter Desmet, MD, Principal investigator, K.U. Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232856
- Sponsor's protocol ID
- EC01-06
- Acronym
- TROPICAL
- Status last verified
- Apr 2008
- First submitted
- 4 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
- A Multi-Center, Non-Randomised Study of the CYPHER™ Sirolimus-Eluting Stent in the Treatment of Patient With an in-Stent Restenotic Native Coronary Artery Lesion
- ClinicalTrials.gov ID
- NCT00232856
- Acronym / sponsor ID
- TROPICAL / EC01-06
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Aug 2006 (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™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
Detailed description
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: drug-eluting stentCypher™ sirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has an in-stent restenosis of ≥ 60% and < 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery.
- The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion.
Key exclusion criteria (4 listed)
- Unprotected left main coronary disease with ≥ 50% stenosis;
- Patient previously treated with brachytherapy in any coronary vessel.
- Target lesion involves bifurcation including a side branch >2.5mm in diameter.
- The patient sustained a recent (<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.
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: Cypher™ sirolimus-eluting stentPCI | Device | 1 |
Primary outcome
angiographic in-lesion late loss
Time frame: 6 months post-procedure
7 secondary outcomes
in-stent mean percent diameter stenosis (%DS)
Time frame: 6-months post-procedure
i-stent late loss (LL)
Time frame: 6 months post-procedure
in-lesion binary restenosis
Time frame: 6-months post-procedure
Target Vessel Revascularization (TVR)
Time frame: 9-months post-procedure
Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel
Time frame: 9 months post-procedure
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 in-hospital
Time frame: 1, 6, 9 months and, 2 and 3 years post-procedure
occurrence of bleeding
Time frame: 1, 6, 9 months and, 2 and 3 years 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.
Franz-Josef Neumann, MD principal investigator
Herz-zentrum Bad Krozingen
Walter Desmet, MD principal investigator
K.U. Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing drug-eluting stent in people with Coronary Artery Disease, run by Cordis US Corp. at 2 sites in 2 countries.
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 2 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 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 2 sites in Belgium, Germany. 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?
angiographic in-lesion late loss (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.