Coronary DiseasePhase 3NCT00322543
Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)
A Phase 3 study testing Corio™ Pimecrolimus-eluting stent in people with Coronary Disease, run by Conor Medsystems at 1 site in Brazil.
Trial summary
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Corio™ Pimecrolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBrazil
- Study dates
- May 2006to May 2008
- 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
- General Inclusion Criteria
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable or unstable angina pectoris
- Left ventricular ejection fraction (LVEF) ≥25%
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
- Target Lesion < 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.
Who cannot join
- General Exclusion Criteria
- Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
- Planned treatment with any other PCI device in the target vessel(s).
- MI within 72 hours prior to the index procedure
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
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- Acute or chronic renal dysfunction
- Contraindication to ASA or to clopidogrel.
- Thrombocytopenia
- Active gastrointestinal (GI) bleeding within the past 3 months.
- Any prior true anaphylactiod reaction to contrast agents
- Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
- Female of childbearing potential.
- Life expectancy of less than 24 months due to other medical conditions.
- Co-morbid condition(s)
- Currently participating in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute Dante Pazzanese of Cardiology
São Paulo, São Paulo, 04012-180
About this study
Official title: Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID) A Multi-Center Study of the Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System (Corio™) in Patients With De Novo Lesions of the Native Coronary Arteries
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.
Read the detailed description
The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.
- Conditions
- Coronary Disease
- Being tested
- Corio™ Pimecrolimus-eluting stent
- Keywords
- Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corio™ Pimecrolimus-eluting stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Drug eluting stent | Experimental | Corio™ Pimecrolimus-eluting stent Receives: Device: Corio™ Pimecrolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic endpoint of in-stent late lumen loss at 6 months
Measured: 6 months
Secondary outcomes (2)
Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;
Measured: 30 days, 6 months, 12 months and 2 years
Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.
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 posted8 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2006
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conor Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alexandre Abizaid, M.D., Principal investigator, Institute Dante Pazzanese of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322543
- Sponsor's protocol ID
- RAPID (Genesis) Registry CP-02
- Status last verified
- Sep 2008
- First submitted
- 4 May 2006
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID) A Multi-Center Study of the Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System (Corio™) in Patients With De Novo Lesions of the Native Coronary Arteries
- ClinicalTrials.gov ID
- NCT00322543
- Acronym / sponsor ID
- RAPID (Genesis) Registry CP-02
- Conditions
- Coronary Disease
- Keywords
- Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Conor MedsystemsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 May 2006 (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.
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.
Detailed description
The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug eluting stent | Experimental | Device: Corio™ Pimecrolimus-eluting stentCorio™ Pimecrolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- General Inclusion Criteria
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable or unstable angina pectoris
- Left ventricular ejection fraction (LVEF) ≥25%
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
Key exclusion criteria (16 listed)
- General Exclusion Criteria
- Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
- Planned treatment with any other PCI device in the target vessel(s).
- MI within 72 hours prior to the index procedure
- The patient is in cardiogenic shock.
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 |
|---|---|---|
| Corio™ Pimecrolimus-eluting stent | Device | Drug eluting stent |
Primary outcome
Angiographic endpoint of in-stent late lumen loss at 6 months
Time frame: 6 months
2 secondary outcomes
Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;
Time frame: 30 days, 6 months, 12 months and 2 years
Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 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.
Alexandre Abizaid, M.D. principal investigator
Institute Dante Pazzanese of Cardiology
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 Corio™ Pimecrolimus-eluting stent in people with Coronary Disease, run by Conor Medsystems at 1 site in Brazil.
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 16 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: stopped early, as of the sponsor's last update on 17 Oct 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 Brazil. 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 was stopped early. Results are not available in the source record.
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 endpoint of in-stent late lumen loss at 6 months (time frame: 6 months). 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 17 Oct 2008.