- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01373502
International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions (NEXT)
April 27, 2018 updated by: CID - Carbostent & Implantable Devices
International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
323
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium
- Academisch Ziekenhuis Middelheim
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Genk, Belgium
- Ziekenhuis Oost Limburg
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Nimes, France
- Clinique Les Franciscaines
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Paris, France
- Institut Mutualiste Montsouris
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Rouen, France
- Clinique Saint-Hilaire
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Toulouse Cedex 4, France
- Hôpital de Rangueil
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Hamburg, Germany
- Medizinisches Versorgungszentrum
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Trier, Germany
- Krankenhaus der Barmherzigen Brüder
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Firenze, Italy
- Azienda Ospedaliera Careggi
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Massa, Italy
- Istituto di Fisiologia Clinica del CNR
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Roma, Italy
- Ospedale S. Camillo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DES Limus Carbostent Coronary Stent
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DES Limus Carbostent Carbofilm Coated Coronary Stent
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Active Comparator: Taxus Liberté Coronary Stent
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Taxus Liberté Coronary Stent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
angiographic efficacy measurement (mm)
Time Frame: 180 days
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in-stent Late Lumen Loss (LLL) measurement by angiography
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180 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute success (Device and Procedural success)
Time Frame: acute
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acute
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QCA measurements in-stent and in-segment
Time Frame: 180 days
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180 days
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IVUS measurements
Time Frame: 180 days
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180 days
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Incidence of cardiac death (%)
Time Frame: 30 days, 180 days, 1, 2 , 3, 4 and 5 years
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30 days, 180 days, 1, 2 , 3, 4 and 5 years
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Stent Thrombosis
Time Frame: acute, 30 days, 180 days, 1 year, > 1 year
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acute, 30 days, 180 days, 1 year, > 1 year
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Incidence of Myocardial Infarction (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
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30 days, 180 days, 1, 2, 3, 4, 5 years
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Incidence of clinically indicated TLR (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
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30 days, 180 days, 1, 2, 3, 4, 5 years
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Incidence of all deaths (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
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30 days, 180 days, 1, 2, 3, 4, 5 years
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Incidence of all repeat revascularization (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
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30 days, 180 days, 1, 2, 3, 4, 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Didier Carrié, Prof, Hôpital de Rangueil, Toulouse Cedex 4 - France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
June 14, 2011
First Posted (Estimate)
June 15, 2011
Study Record Updates
Last Update Posted (Actual)
April 30, 2018
Last Update Submitted That Met QC Criteria
April 27, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C20902
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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