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

NCT00322569 | Completed Phase 3 DMC

• 1 other identifier: CP-01
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease

Keywords

Percutaneous coronary intervention (PCI); Drug eluting stent (DES)

Outcome Measures

Primary Outcomes (1)

• Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA)

  6 months post-procedure

Secondary Outcomes (12)

• MACE (composite of non-cardiac death, new Qw/nonQw MI, and TVR) as described below

  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.

  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.

  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.

  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).

  30 days and 6 months, 1, 2, 3, 4, and 5 years post-procedure

Study Arms (3)

1

EXPERIMENTAL

Corio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System

Device: Corio™ Pimecrolimus-Eluting Coronary Stent System

2

EXPERIMENTAL

SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System

Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System

Control Arm

ACTIVE COMPARATOR

Costar ™ Paclitaxel-Eluting Coronary Stent System

Device: Costar ™ Paclitaxel-Eluting Coronary Stent System

Interventions

Corio™ Pimecrolimus-Eluting Coronary Stent System DEVICE

Drug-eluting stent

1

SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System DEVICE

Drug-eluting stent

2

Costar ™ Paclitaxel-Eluting Coronary Stent System DEVICE

Drug-eluting Stent

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cordis US Corp.: lead
• Conor Medsystems: collaborator

Study Sites (1)

Southampton University Hospital

Southampton, SO16 YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 19463427 RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Nicholas Curzen, M.D.

  Southampton University Hospital

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, M.D.

  AZ Middelheim Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 8, 2006
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2012
• Last Updated: March 6, 2013

Record last verified: 2013-03

Locations

GB (1)