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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00699543
• Other study ID #: ECO-PLEASANT
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 16, 2008
• Last updated: December 15, 2013
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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

B. Angiographic efficacy end points

1. in-stent binary restenosis by QCA

2. in-stent and in-lesion late loss by QCA

3. in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 915
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• General Inclusion Criteria

1. Subject must be at least 18 years of age.

2. 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.

3. 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

1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of = 2.5 mm and = 4.0 mm.

2. Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria

• General Exclusion Criteria

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

• Heparin

• Aspirin

• Both Clopidogrel and Ticlopidine

• Paclitaxel

• 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.

2. Systemic (intravenous) Paclitaxel use within 12 months.

3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

4. History of bleeding diathesis or known coagulopathy (including heparin- induced thrombocytopenia), or will refuse blood transfusions.

5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

6. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.

7. 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).

8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

9. Patients with LVEF<25% or those with cardiogenic shock

10. Patients with acute ST elevation myocardial infarction who requires primary PCI

11. Patients with acute ST elevation myocardial infarction within 48hrs

12. Creatinine level = 3.0mg/dL or dependence on dialysis.

• Angiographic Exclusion Criteria

1. Patients with significant left main stem stenosis which requires revascularization therapy

2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents

3. Target lesions with bifurcating disease which require side branch stenting

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coroflex Please stent implantation
Use Coroflex Please stent in the treatment of coronary stenosis
• Taxus stent implantation
Use Taxus stent in the treatment of coronary stenosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	B. Braun Melsungen AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically driven Target vessel Revascularization (TVR)		9 months.	Yes
Secondary	Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR)		1, 4, 9, 12 months and 2, 3years	Yes
Secondary	Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR)		1, 4, 9, 12 months and 2, 3years	Yes
Secondary	Stent thrombosis		1, 4, 9, 12 months and 2, 3years	Yes
Secondary	In-stent binary restenosis by QCA		9 months	No
Secondary	In-stent and in-lesion late loss by QCA		9 months	No
Secondary	In-stent and in-lesion MLD and percentage diameter stenosis by QCA		Immediately after the index procedure and at 9 months	No