International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions
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1 other identifier
interventional
323
4 countries
11
Brief Summary
The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 15, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 30, 2018
April 1, 2018
1.5 years
September 24, 2010
April 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
angiographic efficacy measurement (mm)
in-stent Late Lumen Loss (LLL) measurement by angiography
180 days
Secondary Outcomes (9)
QCA measurements in-stent and in-segment
180 days
IVUS measurements
180 days
Incidence of cardiac death (%)
30 days, 180 days, 1, 2 , 3, 4 and 5 years
Stent Thrombosis
acute, 30 days, 180 days, 1 year, > 1 year
Acute success (Device and Procedural success)
acute
- +4 more secondary outcomes
Study Arms (2)
DES Limus Carbostent Coronary Stent
EXPERIMENTALTaxus Liberté Coronary Stent
ACTIVE COMPARATORInterventions
DES Limus Carbostent Carbofilm Coated Coronary Stent
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Patient is eligible for percutaneous coronary intervention (PCI) and for surgical revascularization (CABG)
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site
- Patients with clinical evidence of ischemic heart disease and/or a positive functional study(e.g. stress test); documented stable (CCS I-IV) or unstable angina pectoris (Braunwald class I-II B and C) or documented silent ischemia
- LVEF\>30%
You may not qualify if:
- Target lesion should be located in a target vessel with a diameter ranging from 3.0 to 3.75 mm
- Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of ≥ 1
- The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm). Any occurred dissection of the target vessel must be treated with an additional stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm)
- Patient that underwent BMS implantation more than 6 months before the enrolment or DES implantation more than 1 year before the enrolment in an other vessel.
- Female with childbearing potential or lactating
- Known sensitivity to sirolimus, paclitaxel, the polymeric matrix, stainless steel or cobalt chromium
- Acute Q-wave or non Q-wave myocardial infarction within 72 hours, or presents with CK elevation greater than 2 times upper limit normal associated with elevated CK-MB
- Cardiogenic shock
- Cerebrovascular accident within the past 6 months
- Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl)
- Contraindication to aspirin or clopidogrel
- Thrombocytopenia (platelet count less than 100,000/mm³)
- Active gastrointestinal bleeding within the past 3 months
- Known bleeding or hypercoagulable disorder
- Prior anaphylactic reaction to contrast agents or contrast sensitivity that cannot be controlled with pre-medication
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Academisch Ziekenhuis Middelheim
Antwerp, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
Clinique les Franciscaines
Nîmes, France
Institut Mutualiste Montsouris
Paris, France
Clinique Saint-Hilaire
Rouen, France
Hôpital de Rangueil
Toulouse, France
Medizinisches Versorgungszentrum
Hamburg, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Azienda Ospedaliera Careggi
Florence, Italy
Istituto di Fisiologia Clinica del CNR
Massa, Italy
Ospedale S. Camillo
Roma, Italy
Related Publications (1)
Carrie D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A multicenter randomized trial comparing amphilimus- with paclitaxel-eluting stents in de novo native coronary artery lesions. J Am Coll Cardiol. 2012 Apr 10;59(15):1371-6. doi: 10.1016/j.jacc.2011.12.009. Epub 2012 Jan 25.
PMID: 22284328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Carrié, Prof
Hôpital de Rangueil, Toulouse Cedex 4 - France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2010
First Posted
June 15, 2011
Study Start
October 1, 2009
Primary Completion
April 1, 2011
Study Completion
October 1, 2015
Last Updated
April 30, 2018
Record last verified: 2018-04