- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322569
A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)
March 5, 2013 updated by: Cordis Corporation
A Randomized, Multi-Center Study of the Pimecrolimus-Eluting (Corio™) and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System (SymBio™) in Patients With De Novo Lesions of the Native Coronary Arteries
To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions <25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.
Study Type
Interventional
Enrollment (Actual)
246
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Southampton, United Kingdom, SO16 YD
- Southampton University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 mm to ≤3.5 mm with visually estimated stenosis of ≥50% and < 100% .
- Target vessel had not undergone prior revascularization within the preceding 6 months.
- Target lesion must have been a minimum of 10 mm distance from any previously treated segment of the target vessel
- Patient understood the study requirements and the treatment procedures and provided written Informed Consent, approved by the local Ethics Committee.
- Willing to comply with all specified follow-up evaluations.
Exclusion Criteria:
General Exclusion Criteria
- Known sensitivity to pimecrolimus, paclitaxel, 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.
- 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 colchicine, chronic systemic steroid therapy or systemic immunosuppressant therapy, or or had been treated with paclitaxel (systemic) within 12 months of the index procedure.
- Patient was currently, or was on long term intermittent therapy with 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
General Angiographic Exclusion Criteria:
- Left main coronary artery disease (stenosis >50%), whether protected or unprotected.
- Target lesion was ostial in location (within 3.0 mm of vessel origin).
- Target lesion and/or target vessel proximal to the target lesion was severely calcified by visual estimation.
- Target lesion involved a bifurcation with a diseased (>50% stenotic) branch vessel >2.0 mm in diameter that required intervention.
- Target lesion was totally occluded Thrombolysis In MI (TIMI flow 0) or TIMI flow ≤1.
- Angiographic presence of probable or definite thrombus.
- Target vessel would have been pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement.
- Prior coronary intervention using brachytherapy to any segment of the target vessel.
- The target vessel had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site within preceding 6 months.
- Angiographic restenosis of any segment of the target vessel that had undergone prior percutaneous coronary intervention.
- Angiographic evidence of atherosclerotic disease with >50% diameter stenosis (by visual estimate) proximal or distal to the target lesion (applies to the major epicardial portion of the target vessel and contiguous vessel segment if the target lesion was located in a branch vessel).
- Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit).
- Target lesion lied within 10mm of prior surgical anastomosis site.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Corio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System
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Drug-eluting stent
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Experimental: 2
SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
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Drug-eluting stent
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Active Comparator: Control Arm
Costar ™ Paclitaxel-Eluting Coronary Stent System
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Drug-eluting Stent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA)
Time Frame: 6 months post-procedure
|
6 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE (composite of non-cardiac death, new Qw/nonQw MI, and TVR) as described below
Time Frame: 30 days and 6 months
|
Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of death that cannot be clearly attributed to a non-cardiac event or non-intervention vessel, new myocardial infarction (Q-wave or non-Q-wave) that cannot be clearly attributed to a non-intervention vessel and clinically driven target vessel revascularization (TVR)
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30 days and 6 months
|
Primary Device Success defined as attainment of <50% in-stent residual stenosis of the target lesion using only the assigned device in the absence of device malfunction and device-related complication.
Time Frame: 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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|
Lesion Success defined as attainment of <50% residual stenosis of the target lesion using the assigned study device or any percutaneous method.
Time Frame: 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
|
|
Procedure Success defined as attainment of final lesion success in the absence of in-hospital MACE.
Time Frame: 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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|
Angiographic in-stent and in-segment binary restenosis (≥50% diameter stenosis).
Time Frame: 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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In-stent and in-segment MLD
Time Frame: 6 months post-procedure
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6 months post-procedure
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In-segment angiographic late loss
Time Frame: 6 months post-procedure
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6 months post-procedure
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Clinically driven Target Lesion Revascularization (TLR)
Time Frame: 6 months post-procedure
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6 months post-procedure
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Percent volume obstruction of the stent by intravascular ultrasound (IVUS) in the IVUS cohort.
Time Frame: 6 months post-procedure
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6 months post-procedure
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Incidence of late acquired incomplete stent to vessel apposition (stent malapposition) by IVUS in the IVUS cohort.
Time Frame: 6 months post-procedure
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6 months post-procedure
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Incidence of reported MACE
Time Frame: 1, 2, 3, 4 and 5 years post-procedure
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1, 2, 3, 4 and 5 years post-procedure
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Comparison of the pimecrolimus-eluting stent to the pimecrolimus/paclitaxel-eluting stent for primary and secondary endpoints.
Time Frame: 30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas Curzen, M.D., Southampton University Hospital
- Principal Investigator: Stefan Verheye, M.D., AZ Middelheim Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
May 4, 2006
First Submitted That Met QC Criteria
May 4, 2006
First Posted (Estimate)
May 8, 2006
Study Record Updates
Last Update Posted (Estimate)
March 6, 2013
Last Update Submitted That Met QC Criteria
March 5, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Calcineurin Inhibitors
- Paclitaxel
- Albumin-Bound Paclitaxel
- Tacrolimus
- Pimecrolimus
Other Study ID Numbers
- CP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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