International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions (NEXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier:
NCT01373502
First received: September 24, 2010
Last updated: February 20, 2012
Last verified: February 2012

September 24, 2010
February 20, 2012
October 2009
April 2011   (final data collection date for primary outcome measure)
angiographic efficacy measurement (mm) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
in-stent Late Lumen Loss (LLL) measurement by angiography
Same as current
Complete list of historical versions of study NCT01373502 on ClinicalTrials.gov Archive Site
  • QCA measurements in-stent and in-segment [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • IVUS measurements [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Incidence of cardiac death (%) [ Time Frame: 30 days, 180 days, 1, 2 , 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis [ Time Frame: acute, 30 days, 180 days, 1 year, > 1 year ] [ Designated as safety issue: Yes ]
  • Acute success (Device and Procedural success) [ Time Frame: acute ] [ Designated as safety issue: Yes ]
  • Incidence of Myocardial Infarction (%) [ Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of clinically indicated TLR (%) [ Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]
  • Incidence of all deaths (%) [ Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of all repeat revascularization (%) [ Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stable Angina
  • Unstable Angina
  • Documented Silent Ischemia
  • Device: DES Limus Carbostent
    DES Limus Carbostent Carbofilm Coated Coronary Stent
  • Device: Taxus Liberté Stent
    Taxus Liberté Coronary Stent
  • Experimental: DES Limus Carbostent Coronary Stent
    Intervention: Device: DES Limus Carbostent
  • Active Comparator: Taxus Liberté Coronary Stent
    Intervention: Device: Taxus Liberté Stent
Carrié 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
323
September 2015
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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%
  • Requires treatment of a single de novo lesion in a native coronary artery in one or two different major epicardial vessels (LAD, LCX or RCA). The second lesion must fit with inclusion/exclusion criteria and must be treated with the same study stent as the first lesion
  • 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.

Exclusion Criteria:

  • 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
  • Currently under immunosuppressant therapy
  • Currently, or has been treated with either Rapamune or paclitaxel within 12 months of the procedure
  • Active infection
  • Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
  • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study
  • Patient underwent coronary revascularization to any vessel within 30 days
  • Patient underwent target vessel revascularization within 6 months
  • Target vessel has had prior stent placement
  • Presence of two lesions located in the same vascular territory (same major epicardial vessel)
  • Prior coronary brachytherapy
  • There is a planned target lesion treatment with any technique other than the pre-dilatation balloon angioplasty
  • Treatment of more than two lesions is required at the time of enrolment, or is planned within 30 days following enrolment
  • Any planned surgery within 6 months after index procedure
  • Left main disease greater than 50% diameter stenosis
  • Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off
  • Heavily calcified vessel and/or lesion which cannot be successfully predilated
  • Target lesion is located or supplied by an arterial or venous bypass graft
  • Ostial target lesion or lesion located within 2 mm of a bifurcation
  • Target lesion involves a side branch >2.0 mm in diameter with an ostial disease
  • Target lesion has TIMI 0 flow
  • Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   France,   Germany
 
NCT01373502
C20902
No
CID s.r.l. (Cristina Isaia- Clinical Affairs Director), CID s.r.l.
CID - Carbostent & Implantable Devices
Not Provided
Principal Investigator: Didier Carrié, Prof Hôpital de Rangueil, Toulouse Cedex 4 - France
CID - Carbostent & Implantable Devices
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP