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

This study has been completed.
Sponsor:
Collaborator:
Conor Medsystems
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00322569
First received: May 4, 2006
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Device: Corio™ Pimecrolimus-Eluting Coronary Stent System
Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Device: Costar ™ Paclitaxel-Eluting Coronary Stent System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA) [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MACE (composite of non-cardiac death, new Qw/nonQw MI, and TVR) as described below [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • In-stent and in-segment MLD [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • In-segment angiographic late loss [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Clinically driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]
  • Percent volume obstruction of the stent by intravascular ultrasound (IVUS) in the IVUS cohort. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Incidence of late acquired incomplete stent to vessel apposition (stent malapposition) by IVUS in the IVUS cohort. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: No ]
  • Incidence of reported MACE [ Time Frame: 1, 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: July 2006
Study Completion Date: May 2012
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Corio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System
Device: Corio™ Pimecrolimus-Eluting Coronary Stent System
Drug-eluting stent
Experimental: 2
SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Drug-eluting stent
Active Comparator: Control Arm
Costar ™ Paclitaxel-Eluting Coronary Stent System
Device: Costar ™ Paclitaxel-Eluting Coronary Stent System
Drug-eluting Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322569

Locations
United Kingdom
Southampton University Hospital
Southampton, United Kingdom, SO16 YD
Sponsors and Collaborators
Cordis Corporation
Conor Medsystems
Investigators
Principal Investigator: Nicholas Curzen, M.D. Southampton University Hospital
Principal Investigator: Stefan Verheye, M.D. AZ Middelheim Hospital
  More Information

Publications:
Verheye,S et al. The GENESIS (Randomized Multi-center Study of the Pimecrolimus-eluting and Pimecrolimus/Paclitaxel-eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries)Trial. J Am Coll Cardiol Intv 2009;2:205-214

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00322569     History of Changes
Other Study ID Numbers: CP-01
Study First Received: May 4, 2006
Last Updated: March 5, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Cordis Corporation:
Percutaneous coronary intervention (PCI)
Drug eluting stent (DES)

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Pimecrolimus
Tacrolimus
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 23, 2014