A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)
NCT ID: NCT00322569
Last Updated: 2013-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
246 participants
INTERVENTIONAL
2006-07-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Corio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System
Corio™ Pimecrolimus-Eluting Coronary Stent System
Drug-eluting stent
2
SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Drug-eluting stent
Control Arm
Costar ™ Paclitaxel-Eluting Coronary Stent System
Costar ™ Paclitaxel-Eluting Coronary Stent System
Drug-eluting Stent
Interventions
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Corio™ Pimecrolimus-Eluting Coronary Stent System
Drug-eluting stent
SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Drug-eluting stent
Costar ™ Paclitaxel-Eluting Coronary Stent System
Drug-eluting Stent
Eligibility Criteria
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Inclusion Criteria
2. Documented stable or unstable angina pectoris
3. Left ventricular ejection fraction (LVEF) ≥25%
4. Acceptable candidate for coronary artery bypass graft surgery (CABG).
5. Target lesion \< 25 mm in length with RVD of ≥2.5 mm to ≤3.5 mm with visually estimated stenosis of ≥50% and \< 100% .
6. Target vessel had not undergone prior revascularization within the preceding 6 months.
7. Target lesion must have been a minimum of 10 mm distance from any previously treated segment of the target vessel
8. Patient understood the study requirements and the treatment procedures and provided written Informed Consent, approved by the local Ethics Committee.
9. Willing to comply with all specified follow-up evaluations.
Exclusion Criteria
2. Planned treatment with any other PCI device in the target vessel(s).
3. MI within 72 hours prior to the index procedure
4. The patient is in cardiogenic shock.
5. Cerebrovascular Accident (CVA) within the past 6 months.
6. Acute or chronic renal dysfunction
7. Contraindication to ASA or to clopidogrel.
8. Thrombocytopenia
9. Active gastrointestinal (GI) bleeding within the past 3 months.
10. Any prior true anaphylactiod reaction to contrast agents
11. 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.
12. Patient was currently, or was on long term intermittent therapy with topical pimecrolimus
13. Female of childbearing potential.
14. Life expectancy of less than 24 months due to other medical conditions.
15. Co-morbid condition(s)
16. Currently participating in another investigational drug or device study
1. Left main coronary artery disease (stenosis \>50%), whether protected or unprotected.
2. Target lesion was ostial in location (within 3.0 mm of vessel origin).
3. Target lesion and/or target vessel proximal to the target lesion was severely calcified by visual estimation.
4. Target lesion involved a bifurcation with a diseased (\>50% stenotic) branch vessel \>2.0 mm in diameter that required intervention.
5. Target lesion was totally occluded Thrombolysis In MI (TIMI flow 0) or TIMI flow ≤1.
6. Angiographic presence of probable or definite thrombus.
7. 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.
8. Prior coronary intervention using brachytherapy to any segment of the target vessel.
9. The target vessel had prior drug-eluting stent placement to vessel segment (or branch) proximal to intended target lesion site within preceding 6 months.
10. Angiographic restenosis of any segment of the target vessel that had undergone prior percutaneous coronary intervention.
11. 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).
12. Prior surgical revascularization of the target vessel with patent graft (saphenous vein graft or arterial conduit).
13. Target lesion lied within 10mm of prior surgical anastomosis site.
18 Years
ALL
No
Sponsors
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Conor Medsystems
INDUSTRY
Cordis Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Curzen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Southampton University Hospital
Stefan Verheye, M.D.
Role: PRINCIPAL_INVESTIGATOR
AZ Middelheim Hospital
Locations
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Southampton University Hospital
Southampton, , United Kingdom
Countries
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References
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Verheye S, Agostoni P, Dawkins KD, Dens J, Rutsch W, Carrie D, Schofer J, Lotan C, Dubois CL, Cohen SA, Fitzgerald PJ, Lansky AJ. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) trial. JACC Cardiovasc Interv. 2009 Mar;2(3):205-14. doi: 10.1016/j.jcin.2008.12.011.
Other Identifiers
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CP-01
Identifier Type: -
Identifier Source: org_study_id
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