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Coronary DiseasePhase 3NCT00322569

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

A Phase 3 study testing Corio™ Pimecrolimus-Eluting Coronary Stent System, SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System and Costar ™ Paclitaxel-Eluting Coronary Stent System in people with Coronary Disease, run by Cordis US Corp. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Corio™ Pimecrolimus-Eluting Coronary Stent System, SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System and Costar ™ Paclitaxel-Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2006to May 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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% .
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Southampton University Hospital

    Southampton, SO16 YD

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Corio™ Pimecrolimus-Eluting Coronary Stent System, SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System, Costar ™ Paclitaxel-Eluting Coronary Stent System
Keywords
Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corio™ Pimecrolimus-Eluting Coronary Stent SystemDevice

    Drug-eluting stent

  • SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent SystemDevice

    Drug-eluting stent

  • Costar ™ Paclitaxel-Eluting Coronary Stent SystemDevice

    Drug-eluting Stent

Study groups in NCT00322569
Study groupRoleWhat they receive
1ExperimentalCorio™ Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System
Receives: Device: Corio™ Pimecrolimus-Eluting Coronary Stent System
2ExperimentalSymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Receives: Device: SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System
Control ArmActive comparatorCostar ™ Paclitaxel-Eluting Coronary Stent System
Receives: Device: Costar ™ Paclitaxel-Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months post-procedure

Secondary outcomes (12)

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

    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)

    Measured: 30 days and 6 months

  2. 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.

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

  3. Lesion Success defined as attainment of <50% residual stenosis of the target lesion using the assigned study device or any percutaneous method.

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

  4. Procedure Success defined as attainment of final lesion success in the absence of in-hospital MACE.

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

  5. Angiographic in-stent and in-segment binary restenosis (≥50% diameter stenosis).

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

  6. In-stent and in-segment MLD

    Measured: 6 months post-procedure

  7. In-segment angiographic late loss

    Measured: 6 months post-procedure

  8. Clinically driven Target Lesion Revascularization (TLR)

    Measured: 6 months post-procedure

  9. Percent volume obstruction of the stent by intravascular ultrasound (IVUS) in the IVUS cohort.

    Measured: 6 months post-procedure

  10. Incidence of late acquired incomplete stent to vessel apposition (stent malapposition) by IVUS in the IVUS cohort.

    Measured: 6 months post-procedure

  11. Incidence of reported MACE

    Measured: 1, 2, 3, 4 and 5 years post-procedure

  12. Comparison of the pimecrolimus-eluting stent to the pimecrolimus/paclitaxel-eluting stent for primary and secondary endpoints.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2007
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00322569
Sponsor's protocol ID
CP-01
Status last verified
Mar 2013
First submitted
4 May 2006
Last updated
6 Mar 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19463427

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Corio™ Pimecrolimus-Eluting Coronary Stent System, SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System and Costar ™ Paclitaxel-Eluting Coronary Stent System in people with Coronary Disease, run by Cordis US Corp. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary angiographic late loss in the stent as measured by Quantitative Coronary Angiography (QCA) (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.

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