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Coronary Artery DiseasePhase 3NCT00699543

The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention

A Phase 3 study testing Coroflex Please stent implantation and Taxus stent implantation in people with Coronary Artery Disease, run by Seoul National University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objectives : To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Coroflex Please stent implantation and Taxus stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
915 participants
Where
No sites listed yet
Study dates
Jul 2008to Dec 2013
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
  • Subject must be at least 18 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • Subject must have coronary artery stenosis (>50% by visual estimate) with evidence of myocardial ischemia (e.g., stable, unstable angina, myocardial infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia.) or Subject must have significant coronary artery stenosis (>70% by visual estimate)
  • Angiographic Inclusion Criteria
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
  • Target lesion(s) must be amenable for percutaneous coronary intervention

Who cannot join

  • General Exclusion Criteria
  • The patient has a known hypersensitivity or contraindication to any of the following medications:
  • Heparin
  • Aspirin
  • Both Clopidogrel and Ticlopidine
  • Paclitaxel
Show all 23Show fewer
  • Stainless steel
  • Contrast media(*) (*)Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
  • Systemic (intravenous) Paclitaxel use within 12 months.
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • History of bleeding diathesis or known coagulopathy (including heparin- induced thrombocytopenia), or will refuse blood transfusions.
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Patients with LVEF<25% or those with cardiogenic shock
  • Patients with acute ST elevation myocardial infarction who requires primary PCI
  • Patients with acute ST elevation myocardial infarction within 48hrs
  • Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
  • Angiographic Exclusion Criteria
  • Patients with significant left main stem stenosis which requires revascularization therapy
  • Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
  • Target lesions with bifurcating disease which require side branch stenting

About this study

Official title: The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention: Comparison or Efficacy Between COroflex PLEASe ANd TaxusTM Stent

Objectives

: To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis.

Read more

Study Design

: Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length > 28mm)

Patient Enrollment

:915 patients enrolled at 13 centers in Korea.

Patient Follow-Up

:Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint

:Clinically driven Target vessel Revascularization (TVR) at 9 months.

Secondary Endpoints

:A. Clinical safety and efficacy end points

  1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)
  2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)
  3. Stent thrombosis
  4. Angiographic efficacy end points
  5. in-stent binary restenosis by QCA
  6. in-stent and in-lesion late loss by QCA
  7. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up
Being tested
Coroflex Please stent implantation, Taxus stent implantation
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Coroflex Please stent implantationDevice

    Also called Coroflex Please stent

    Use Coroflex Please stent in the treatment of coronary stenosis

  • Taxus stent implantationDevice

    Also called Taxus stent

    Use Taxus stent in the treatment of coronary stenosis

Study groups in NCT00699543
Study groupRoleWhat they receive
CExperimentalCoroflex Please stent implantation
Receives: Device: Coroflex Please stent implantation
TActive comparatorTaxus stent implantation
Receives: Device: Taxus stent implantation

What is being measured

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

  1. Clinically driven Target vessel Revascularization (TVR)

    Measured: 9 months.

Secondary outcomes (6)

  1. Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)

    Measured: 1, 4, 9, 12 months and 2, 3years

  2. Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)

    Measured: 1, 4, 9, 12 months and 2, 3years

  3. Stent thrombosis

    Measured: 1, 4, 9, 12 months and 2, 3years

  4. In-stent binary restenosis by QCA

    Measured: 9 months

  5. In-stent and in-lesion late loss by QCA

    Measured: 9 months

  6. In-stent and in-lesion MLD and percentage diameter stenosis by QCA

    Measured: Immediately after the index procedure and at 9 months

Timeline

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

  1. First posted18 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

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
915 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00699543
Sponsor's protocol ID
ECO-PLEASANT
Status last verified
Dec 2013
First submitted
16 Jun 2008
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Seo JB, Kang SH, Hur SH, Park KW, Youn TJ, Park JS, Yang HM, Lee HY, Kang HJ, Koo BK, Bae JH, Kim SW, Moon KW, Choi JW, Lee SG, Chung WY, Kim SJ, Kim DI, Kim BO, Hyon MS, Park KS, Cha TJ, Yoo CW, Jeon HK, Kim HS. Randomized trial comparing the efficacy between different types of paclitaxel-eluting stents: the comparison of efficacy between COroflex PLEASe ANd Taxus stent (ECO-PLEASANT) randomized controlled trial. Am Heart J. 2013 May;165(5):733-43. doi: 10.1016/j.ahj.2013.02.009. Epub 2013 Mar 20.

    PubMed 23622910

  • Seo JB, Jeon HK, Park KW, Park JS, Bae JH, Kim SW, Moon KW, Choi JW, Lee SG, Chung WY, Youn TJ, Kim SJ, Kim DI, Kim BO, Hyon MS, Park KS, Cha TJ, Hwang HK, Hur SH, Kim HS. Efficacies of the new paclitaxel-eluting Coroflex Please stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please and Taxus (ECO-PLEASANT) trial: study rationale and design. Trials. 2009 Oct 23;10:98. doi: 10.1186/1745-6215-10-98.

    PubMed 19849864

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coroflex Please stent implantation and Taxus stent implantation in people with Coronary Artery Disease, run by Seoul National University Hospital.

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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Clinically driven Target vessel Revascularization (TVR) (time frame: 9 months.). 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 NCT00699543, which also lists 2 linked publications.

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 17 Dec 2013.

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