Stable AnginaNEXTNCT01373502
International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions
A study testing DES Limus Carbostent and Taxus Liberté Stent in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, Documented Silent Ischemia
- What is being tested?
- DES Limus Carbostent and Taxus Liberté Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Oct 2009to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
France4 sites
Clinique les Franciscaines
Nîmes
Institut Mutualiste Montsouris
Paris
Clinique Saint-Hilaire
Rouen
Hôpital de Rangueil
Toulouse
Italy3 sites
Azienda Ospedaliera Careggi
Florence
Istituto di Fisiologia Clinica del CNR
Massa
Ospedale S. Camillo
Roma
Belgium2 sites
Academisch Ziekenhuis Middelheim
Antwerp
Ziekenhuis Oost Limburg
Genk
Germany2 sites
Medizinisches Versorgungszentrum
Hamburg
Krankenhaus der Barmherzigen Brüder
Trier
About this study
Official title: 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.
- Conditions
- Stable Angina, Unstable Angina, Documented Silent Ischemia
- Being tested
- DES Limus Carbostent, Taxus Liberté Stent
- Medical subject headings
- Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DES Limus CarbostentDevice
DES Limus Carbostent Carbofilm Coated Coronary Stent
Taxus Liberté StentDevice
Taxus Liberté Coronary Stent
| Study group | Role | What they receive |
|---|---|---|
| DES Limus Carbostent Coronary Stent | Experimental | Not described Receives: Device: DES Limus Carbostent |
| Taxus Liberté Coronary Stent | Active comparator | Not described Receives: Device: Taxus Liberté Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic efficacy measurement (mm)
in-stent Late Lumen Loss (LLL) measurement by angiography
Measured: 180 days
Secondary outcomes (9)
QCA measurements in-stent and in-segment
Measured: 180 days
IVUS measurements
Measured: 180 days
Incidence of cardiac death (%)
Measured: 30 days, 180 days, 1, 2 , 3, 4 and 5 years
Stent Thrombosis
Measured: acute, 30 days, 180 days, 1 year, > 1 year
Acute success (Device and Procedural success)
Measured: acute
Incidence of Myocardial Infarction (%)
Measured: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of clinically indicated TLR (%)
Measured: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all deaths (%)
Measured: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all repeat revascularization (%)
Measured: 30 days, 180 days, 1, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID - Carbostent & Implantable Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Carrié, Prof, Principal investigator, Hôpital de Rangueil, Toulouse Cedex 4 - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373502
- Sponsor's protocol ID
- C20902
- Acronym
- NEXT
- Status last verified
- Apr 2018
- First submitted
- 24 Sep 2010
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22284328
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.
- ClinicalTrials.gov ID
- NCT01373502
- Acronym / sponsor ID
- NEXT / C20902
- Conditions
- Stable Angina, Unstable Angina, Documented Silent Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- CID - Carbostent & Implantable DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES Limus Carbostent Coronary Stent | Experimental | Device: DES Limus Carbostent |
| Taxus Liberté Coronary Stent | Active comparator | Device: Taxus Liberté Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DES Limus CarbostentDES Limus Carbostent Carbofilm Coated Coronary Stent | Device | DES Limus Carbostent Coronary Stent |
| Taxus Liberté StentTaxus Liberté Coronary Stent | Device | Taxus Liberté Coronary Stent |
Primary outcome
angiographic efficacy measurement (mm)
Time frame: 180 days
in-stent Late Lumen Loss (LLL) measurement by angiography
9 secondary outcomes
QCA measurements in-stent and in-segment
Time frame: 180 days
IVUS measurements
Time frame: 180 days
Incidence of cardiac death (%)
Time frame: 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 success (Device and Procedural success)
Time frame: acute
Incidence of Myocardial Infarction (%)
Time frame: 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
Incidence of all deaths (%)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Derived from this study: PubMed 22284328Carrie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Carrié, Prof principal investigator
Hôpital de Rangueil, Toulouse Cedex 4 - France
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DES Limus Carbostent and Taxus Liberté Stent in people with Stable Angina and Unstable Angina, run by CID - Carbostent & Implantable Devices at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Italy, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
angiographic efficacy measurement (mm) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.