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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
323

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Antwerpen, Belgium
        • Academisch Ziekenhuis Middelheim
      • Genk, Belgium
        • Ziekenhuis Oost Limburg
  • France
      • Nimes, France
        • Clinique Les Franciscaines
      • Paris, France
        • Institut Mutualiste Montsouris
      • Rouen, France
        • Clinique Saint-Hilaire
      • Toulouse Cedex 4, France
        • Hôpital de Rangueil
  • Germany
      • Hamburg, Germany
        • Medizinisches Versorgungszentrum
      • Trier, Germany
        • Krankenhaus der Barmherzigen Brüder
  • Italy
      • Firenze, Italy
        • Azienda Ospedaliera Careggi
      • Massa, Italy
        • Istituto di Fisiologia Clinica del CNR
      • Roma, Italy
        • Ospedale S. Camillo

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
angiographic efficacy measurement (mm)
Time Frame: 180 days
in-stent Late Lumen Loss (LLL) measurement by angiography
180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Acute success (Device and Procedural success)
Time Frame: acute
acute
QCA measurements in-stent and in-segment
Time Frame: 180 days
180 days
IVUS measurements
Time Frame: 180 days
180 days
Incidence of cardiac death (%)
Time Frame: 30 days, 180 days, 1, 2 , 3, 4 and 5 years
30 days, 180 days, 1, 2 , 3, 4 and 5 years
Stent Thrombosis
Time Frame: acute, 30 days, 180 days, 1 year, > 1 year
acute, 30 days, 180 days, 1 year, > 1 year
Incidence of Myocardial Infarction (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of clinically indicated TLR (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all deaths (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all repeat revascularization (%)
Time Frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
30 days, 180 days, 1, 2, 3, 4, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CID - Carbostent & Implantable Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings