Coronary Artery DiseaseKARENCT01004575
Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease
A study testing implantation of Kaname Cobalt-Chromium coronary stent in people with Coronary Artery Disease and Angioplasty, Transluminal, Percutaneous Coronary, run by Terumo Europe N.V. at 17 sites in 5 countries.
Trial summary
The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- implantation of Kaname Cobalt-Chromium coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Oct 2009to 30 Jun 2016
- 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
- Patient is ≥ 18 years old.
- Patient is eligible for PCI and acceptable candidate for CABG.
- Clinical evidence of ischemic heart disease and/or a positive functional study. Documented stable angina pectoris (CCS 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia.
- The target lesion or target vessel meets all the following criteria;a) is a single de novo lesion or restenotic post-PTCA (non-stented) lesion in one native coronary artery.b)The stenosis of target lesion is ≥ 50% and < 100% c)The target lesion length must be ≤ 25 mm d)The target reference vessel diameter must be suitable for treatment with stents between 2.5 and 4.0 mm long
- Patient has been informed of the nature of the study, understands the study requirements and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
- The patient is able to comply with all specified follow-up evaluations.
Who cannot join
- Most recent LVEF of the patient is < 25%.
- Known allergies to the following: aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated).
- A platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- WBC count < 3500 cells/mm3.
- Evidence of MI with positive Troponin within 72 hours of the intended treatment.
- Previous PCI (<30 days) anywhere within the target vessel.
Show all 24Show fewer
- Planned interventional treatment of any non-target vessel <30 days post-procedure will be required. Planned intervention on the target vessel or on a significant lesion of > 50% stenosis anywhere within the target vessel after the index procedure will be required.
- The target lesion requires treatment with a device other than PTCA balloon prior to stent placement. (e.g. but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
- Previous stenting anywhere within the target vessel.
- Target vessel has evidence of thrombus.
- Excessive tortuousity (> 60°) of the target vessel proximal to the target lesion (visual estimate).
- Either of the following characteristics in the target lesion (visual estimate): a)Ostial target lesion or bifurcation lesion b)Target lesion involves a side branch > 2mm in diameter c) Target lesion has excessive tortuousity (> 45°)d)Moderate to severely calcified lesion which can not be successfully predilated e)Target lesion is located in or supplied by an arterial or venous bypass graft f)Significant (> 40%) stenosis proximal or distal to the target lesion. g) A complete occlusion (TIMI flow 0 or 1).
- Target lesion located in left main trunk.
- Stroke or transient ischemic attack < prior 180 days.
- Active peptic ulcer or upper GI bleeding < prior 180 days.
- The patient has bleeding hemorrhagic diathesis or coagulopathy. The patient will refuse a blood transfusion.
- The patient has a widespread peripheral vascular disease.
- Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl).
- The patient requires multiple stent implantations for a tandem lesion.
- Life expectancy < 1 year.
- Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials.
- In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- Patient is in cardiogenic shock.
- Female of child-bearing potential.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
France5 sites
Hopital Cardiovasculaire et Pneumologie Louis Pradel
Lyon, 69677
CHU NORD
Nantes, 44035
Clinique les Franciscaines
Nîmes, 30000
Hopital d'Instructions des Armées du Val de Grace
Paris, 75230
CHU Rangeuil
Toulouse, 31059
Germany3 sites
Klinikum Fulda gAG
Fulda, 36043
Klinikum Ludwigshafen
Ludwigshafen, 67063
Klinikum des Johannes Gutenberg Universität
Mainz, 55131
Italy3 sites
Ospedale Careggi
Florence, 50141
Policlinico Milano
Milan, 20122
Ospedale Civico Palermo
Palermo, 90100
Serbia3 sites
Clinical Centre of serbia
Belgrade, 11000
Clinical Hospital Center Zemun
Belgrade, 11000
Institute for Cardiovascular Disease Dedinje
Belgrade, 11040
Spain3 sites
Hospital Clinico San Carlos
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital Meixoeiro
Vigo, 36214
About this study
Official title: Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease
The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
Read the detailed description
Current treatments for coronary artery disease include conservative treatment (drug therapies) and invasive techniques that help increase blood flow to ischemic or oxygen-deprived regions of the heart. Among the invasive techniques the most frequently used are coronary artery bypass graft surgery (CABG), and percutaneous transluminal coronary angioplasty (PTCA) without or with stents (bare metal stents (BMS) or drug eluting stents (DES)) implantation. However, all of those treatments have limitations and their effectiveness is diminished under certain circumstances. Therefore, it is essential to tailor therapy for each individual patient considering the overall patient's condition, disease severity and progression as well as concomitant diseases. The question of selection of appropriate stent for each individual patient is still unresolved and most of the physicians either follow international or national guidelines or scientific wisdom.
Although the efficacy of DES is undisputable in restenosis prevention, because some patients could have adverse outcomes from a DES, they should be used selectively in those who are most likely to benefit, and in that decision process several important issues should be addressed such as:Patients' adherence to post-stenting therapy, Bleeding risk, Need for elective surgery, Risk for restenosis, Risk for stent thrombosis. It is still believed that many patients will do well with BMSs and that this technology requires further refinements to improve outcome. For the above reasons Terumo has designed the new coronary BMS, Kaname™, a balloon expandable Cobalt-Chromium (CoCr) stent pre-mounted onto a high pressure, semi-compliant balloon on a rapid exchange delivery catheter. The Kaname stent is the subject of the current prospective, multi-centre KARE study.
- Being tested
- implantation of Kaname Cobalt-Chromium coronary stent
- Keywords
- stents, bare metal stents
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantation of Kaname Cobalt-Chromium coronary stentDevice
Also called Kaname, Cobalt-chromium, coronary stent
implantation of Kaname Cobalt-Chromium coronary stent
| Study group | Role | What they receive |
|---|---|---|
| Kaname | Experimental | patients that are treated by implanting Kaname Cobalt-Chromium coronary stent Receives: Device: implantation of Kaname Cobalt-Chromium coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Target vessel failure TVF
Freedom from Target vessel failure TVF defined as composite of clinically driven target vessel revascularization (TVR)myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
Measured: 6 months post-procedure
Secondary outcomes (17)
Freedom from TVF for patients treated with ≥ 3 mm stents.
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with ≥ 3 mm stents.
Measured: 6 months post-procedure
Freedom from TVF for patients treated with 2.5 and 2.75 mm stents
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel) for patients treated with 2.5 and 2.75 mm stents
Measured: 6 months post-procedure
Freedom from TVF
Freedom from Target Vessel Failure (composite of clinically driven TVR, myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel)
Measured: 30 days,12 months and 3 and 5 years post-procedure
Clinically driven target lesion revascularization (TLR) free rate .
Clinically driven target lesion revascularization (TLR) free rate
Measured: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Clinically driven target vessel revascularization (TVR) free rate.
Clinically driven target vessel revascularization (TVR) free rate.
Measured: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device success
Device success defined as achievement of a residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using the assigned device only.
Measured: Baseline procedure
Lesion success
Lesion success defined as the attainment of residual diameter stenosis of < 50% by QCA or < 30% by visual estimate, using any percutaneous method.
Measured: Baseline procedure
Procedure success
Procedure success defined as achievement of a final diameter stenosis of < 50% by QCA or < 30% by visual estimate, using any percutaneous method, without MACE (composite of cardiac death, MI and TLR) .
Measured: During baseline hospital stay
Angiographic in-stent acute gain
Angiographic in-stent acute gain at the end of the procedure
Measured: Baseline procedure
Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
Measured: 6 months post-procedure
Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
Measured: 6 months post-procedure
In-stent late-loss
In-stent late-loss (as measured by QCA) defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up MLD.
Measured: 6 months post-procedure
% Diameter Stenosis, in-stent and in-segment .
% Diameter Stenosis, in-stent and in-segment.
Measured: 6 months post-procedure
Neointimal hyperplasia volume as measured by intravascular ultrasound.
Neointimal hyperplasia volume as measured by intravascular ultrasound at 6 months post-procedure
Measured: 6 months post-procedure
Major adverse cardiac events (MACEs) rate .
Major adverse cardiac events (MACEs: composite of cardiac death,, myocardial infarction and TLR) rate.
Measured: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Serious adverse event rate .
Serious adverse event rate.
Measured: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device failure .
Any device failure
Measured: Baseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Carrie, Prof Dr, Principal investigator, CHU Rangeuil, 31059 Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004575
- Sponsor's protocol ID
- T111E4
- Acronym
- KARE
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2009
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Kaname Cobalt-Chromium Coronary Stent System in the Treatment of Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01004575
- Acronym / sponsor ID
- KARE / T111E4
- Keywords
- stents, bare metal stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 30 Oct 2009 (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 assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
Detailed description
Current treatments for coronary artery disease include conservative treatment (drug therapies) and invasive techniques that help increase blood flow to ischemic or oxygen-deprived regions of the heart. Among the invasive techniques the most frequently used are coronary artery bypass graft surgery (CABG), and percutaneous transluminal coronary angioplasty (PTCA) without or with stents (bare metal stents (BMS) or drug eluting stents (DES)) implantation. However, all of those treatments have limitations and their effectiveness is diminished under certain circumstances. Therefore, it is essential to tailor therapy for each individual patient considering the overall patient's condition, disease severity and progression as well as concomitant diseases. The question of selection of appropriate stent for each individual patient is still unresolved and most of the physicians either follow international or national guidelines or scientific wisdom.
Although the efficacy of DES is undisputable in restenosis prevention, because some patients could have adverse outcomes from a DES, they should be used selectively in those who are most likely to benefit, and in that decision process several important issues should be addressed such as:Patients' adherence to post-stenting therapy, Bleeding risk, Need for elective surgery, Risk for restenosis, Risk for stent thrombosis. It is still believed that many patients will do well with BMSs and that this technology requires further refinements to improve outcome. For the above reasons Terumo has designed the new coronary BMS, Kaname™, a balloon expandable Cobalt-Chromium (CoCr) stent pre-mounted onto a high pressure, semi-compliant balloon on a rapid exchange delivery catheter. The Kaname stent is the subject of the current prospective, multi-centre KARE study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kaname | Experimental | Device: implantation of Kaname Cobalt-Chromium coronary stentpatients that are treated by implanting Kaname Cobalt-Chromium coronary stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ≥ 18 years old.
- Patient is eligible for PCI and acceptable candidate for CABG.
- Clinical evidence of ischemic heart disease and/or a positive functional study. Documented stable angina pectoris (CCS 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia.
- The target lesion or target vessel meets all the following criteria;a) is a single de novo lesion or restenotic post-PTCA (non-stented) lesion in one native coronary artery.b)The stenosis of target lesion is ≥ 50% and < 100% c)The target lesion length must be ≤ 25 mm d)The target reference vessel diameter must be suitable for treatment with stents between 2.5 and 4.0 mm long
- Patient has been informed of the nature of the study, understands the study requirements and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
Key exclusion criteria (24 listed)
- Most recent LVEF of the patient is < 25%.
- Known allergies to the following: aspirin, Clopidogrel bisulfate, Prasugrel or Ticlopidine, heparin, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated).
- A platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- WBC count < 3500 cells/mm3.
- Evidence of MI with positive Troponin within 72 hours of the intended treatment.
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 |
|---|---|---|
| implantation of Kaname Cobalt-Chromium coronary stentAlso: Kaname, Cobalt-chromium, coronary stentimplantation of Kaname Cobalt-Chromium coronary stent | Device | Kaname |
Primary outcome
Freedom from Target vessel failure TVF
Time frame: 6 months post-procedure
Freedom from Target vessel failure TVF defined as composite of clinically driven target vessel revascularization (TVR)myocardial infarction or cardiac death that could not be clearly attributed to a vessel other than the target vessel.
17 secondary outcomes
Freedom from TVF for patients treated with ≥ 3 mm stents.
Time frame: 6 months post-procedure
Freedom from TVF for patients treated with 2.5 and 2.75 mm stents
Time frame: 6 months post-procedure
Freedom from TVF
Time frame: 30 days,12 months and 3 and 5 years post-procedure
Clinically driven target lesion revascularization (TLR) free rate .
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Clinically driven target vessel revascularization (TVR) free rate.
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device success
Time frame: Baseline procedure
Lesion success
Time frame: Baseline procedure
Procedure success
Time frame: During baseline hospital stay
Angiographic in-stent acute gain
Time frame: Baseline procedure
Angiographic in-stent and in-segment binary restenosis rate (≥ 50%) diameter stenosis
Time frame: 6 months post-procedure
Angiographic in-stent, in-segment, proximal, and distal minimum lumen diameter (MLD)
Time frame: 6 months post-procedure
In-stent late-loss
Time frame: 6 months post-procedure
% Diameter Stenosis, in-stent and in-segment .
Time frame: 6 months post-procedure
Neointimal hyperplasia volume as measured by intravascular ultrasound.
Time frame: 6 months post-procedure
Major adverse cardiac events (MACEs) rate .
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Serious adverse event rate .
Time frame: 30 days, 6 and 12 months, 3 and 5 years post-procedure
Device failure .
Time frame: Baseline procedure
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 8 Oct 2019.
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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 Carrie, Prof Dr principal investigator
CHU Rangeuil, 31059 Toulouse, France
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implantation of Kaname Cobalt-Chromium coronary stent in people with Coronary Artery Disease and Angioplasty, Transluminal, Percutaneous Coronary, run by Terumo Europe N.V. at 17 sites in 5 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 6 inclusion and 24 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Germany, Italy, Serbia, Spain. 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?
Freedom from Target vessel failure TVF (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.