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A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)

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ClinicalTrials.gov Identifier: NCT00322569
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : March 6, 2013
Sponsor:
Collaborator:
Conor Medsystems
Information provided by (Responsible Party):
Cordis Corporation

Tracking Information
First Submitted Date  ICMJE May 4, 2006
First Posted Date  ICMJE May 8, 2006
Last Update Posted Date March 6, 2013
Study Start Date  ICMJE July 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA) [ Time Frame: 6 months post-procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2006)
Primary angiographic late loss in the stent at 6 months.
Change History Complete list of historical versions of study NCT00322569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
  • 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)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • In-stent and in-segment MLD [ Time Frame: 6 months post-procedure ]
  • In-segment angiographic late loss [ Time Frame: 6 months post-procedure ]
  • Clinically driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months post-procedure ]
  • Percent volume obstruction of the stent by intravascular ultrasound (IVUS) in the IVUS cohort. [ Time Frame: 6 months post-procedure ]
  • Incidence of late acquired incomplete stent to vessel apposition (stent malapposition) by IVUS in the IVUS cohort. [ Time Frame: 6 months post-procedure ]
  • Incidence of reported MACE [ Time Frame: 1, 2, 3, 4 and 5 years post-procedure ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2006)
MACE defined as cardiac death, new MI, or TVR at 30 days and 6 months, 1, 2, 3, 4 and 5 years; Device, Lesion and Procedure Success; coronary angiography at 6 months; IVUS measurements in IVUS coh
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Disease
Intervention  ICMJE
  • Device: Corio™ Pimecrolimus-Eluting Coronary Stent System
    Drug-eluting stent
  • Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
    Drug-eluting stent
  • Device: Costar ™ Paclitaxel-Eluting Coronary Stent System
    Drug-eluting Stent
Study Arms  ICMJE
  • Experimental: 1
    Corio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System
    Intervention: Device: Corio™ Pimecrolimus-Eluting Coronary Stent System
  • Experimental: 2
    SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
    Intervention: Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
  • Active Comparator: Control Arm
    Costar ™ Paclitaxel-Eluting Coronary Stent System
    Intervention: Device: Costar ™ Paclitaxel-Eluting Coronary Stent System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2008)
246
Original Enrollment  ICMJE
 (submitted: May 4, 2006)
375
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General Inclusion Criteria

  1. Eligible for percutaneous coronary intervention (PCI).
  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:

General Exclusion Criteria

  1. Known sensitivity to pimecrolimus, paclitaxel, the polymer (PLGA) or cobalt chromium.
  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

General Angiographic Exclusion Criteria:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00322569
Other Study ID Numbers  ICMJE CP-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cordis Corporation
Study Sponsor  ICMJE Cordis Corporation
Collaborators  ICMJE Conor Medsystems
Investigators  ICMJE
Principal Investigator: Nicholas Curzen, M.D. Southampton University Hospital
Principal Investigator: Stefan Verheye, M.D. AZ Middelheim Hospital
PRS Account Cordis Corporation
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP