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
  Purpose

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.


Condition Intervention Phase
Stable Angina
Unstable Angina
Documented Silent Ischemia
Device: DES Limus Carbostent
Device: Taxus Liberté Stent
Phase 3

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

Resource links provided by NLM:


Further study details as provided by CID - Carbostent & Implantable Devices:

Primary Outcome Measures:
  • angiographic efficacy measurement (mm) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    in-stent Late Lumen Loss (LLL) measurement by angiography


Secondary Outcome Measures:
  • 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 ]

Enrollment: 323
Study Start Date: October 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DES Limus Carbostent Coronary Stent Device: DES Limus Carbostent
DES Limus Carbostent Carbofilm Coated Coronary Stent
Active Comparator: Taxus Liberté Coronary Stent Device: Taxus Liberté Stent
Taxus Liberté Coronary Stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373502

Locations
Belgium
Academisch Ziekenhuis Middelheim
Antwerpen, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
France
Clinique les Franciscaines
Nimes, France
Institut Mutualiste Montsouris
Paris, France
Clinique Saint-Hilaire
Rouen, France
Hôpital de Rangueil
Toulouse Cedex 4, France
Germany
Medizinisches Versorgungszentrum
Hamburg, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
Italy
Azienda Ospedaliera Careggi
Firenze, Italy
Istituto di Fisiologia Clinica del CNR
Massa, Italy
Ospedale S. Camillo
Roma, Italy
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
Investigators
Principal Investigator: Didier Carrié, Prof Hôpital de Rangueil, Toulouse Cedex 4 - France
  More Information

No publications provided by CID - Carbostent & Implantable Devices

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CID s.r.l. (Cristina Isaia- Clinical Affairs Director), CID s.r.l.
ClinicalTrials.gov Identifier: NCT01373502     History of Changes
Other Study ID Numbers: C20902
Study First Received: September 24, 2010
Last Updated: February 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
Italy: Ministry of Health
Italy: Ethics Committee
Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission

Additional relevant MeSH terms:
Angina, Stable
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014