Coronary Artery DiseaseMULTIBENENCT01531725
MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Biotronik AG.
Trial summary
The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must be at least 18 years old.
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4) or unstable (Braunwald type I, II, III and A, B or C) angina pectoris, or documented silent ischemia.
- Left ventricular ejection fraction (LVEF) > 30% documented within the last 6 weeks.
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent on a form that has been approved the by local Institutional Review Board before any specific test of the study or procedure is performed.
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- Willing to comply with all the specified follow-up evaluations.
- Single target vessels to be treated.
- Single target lesion to be treated.
- Target lesion must be completely coverable by one study stent.
- Total target lesion length <20 mm based on a visual estimate.
- RVD of ≥ 2.0 mm to ≤ 5.0 mm based on a visual estimate.
- Target lesion diameter stenosis ≥ 50% and < 100% based on a visual estimate.
- Target lesion has not undergone prior revascularization up to now.
- Target vessel has not undergone prior revascularization within the preceding 6 months.
- Patient has no child bearing potential, is not pregnant, or intends to become pregnant during the study.
Who cannot join
- Planned treatment with any other PCI device in target vessel except the pre-dilatation balloon.
- MI within 72 hours prior to the index procedure and/or creatine kinase (CK) > 2 times the local laboratory upper limits of normal, measured on the day of the index procedure, associated with elevated MB.
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
- Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
- Contraindication to ASA or to clopidogrel.
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- Known Thrombocytopenia (platelet count 100, 000/mm3).
- Active gastrointestinal (GI) bleeding within the past three months.
- Known allergy to stainless steel or cobalt chromium.
- Any prior true anaphylactic reaction to contrast agents.
- Patient is currently taking colchicine.
- Life expectancy of less than 24 months due to other medical conditions.
- 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.
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- Left main coronary artery disease (stenosis > 50%), whether protected or unprotected.
- Target lesion site is ostial (within 3.0 mm of vessel origin).
- Target lesion and/or target vessel proximal to the target lesion is severely calcified by visual estimation.
- Target lesion involves a bifurcation that requires intervention (usually, side branch >2 mm in diameter).
- Target lesion is totally occluded (100% stenosis usually associated with TIMI flow ≤1).
- Angiographic presence of probable or definite thrombus.
- Target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter prior to stent placement.
- Prior coronary intervention using brachytherapy to any segment of the target vessel.
- Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous coronary intervention.
- Angiographic evidence of atherosclerotic disease with > 50% diameter stenosis (by visual estimate) proximal or distal to the target lesion
- Prior surgical revascularization of the target vessel with a documented patent graft (either a saphenous vein or an arterial conduit).
About this study
Official title: 6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System
The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries.
Read the detailed description
The PRO-Kinetic study is a multi-center, prospective, consecutive non-randomized study enrolling 200 patients with single de novo lesions in native coronary arteries meeting the entry criteria. Those who provide informed consent will be enrolled to receive the PRO-Kinetic stent. Telephone follow-up will be performed at 1 month for all enrolled patients. After 6 months 100 patients will have an angiographic follow-up and 100 patients will be checked by telephone again. Additionally, a clinical telephone follow-up will be performed in all patients after 12 months.
This study is designed to yield data on the clinical safety and efficacy of the PRO-Kinetic stent in the coronary artery application. The Target Vessel Failure Rate after 6 months shall be below 18 % (max. 35 Serious Adverse Events and Expedited Events) to show a safety/performance profile that could be considered in the range of the currently available bare metal stent systems
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention
- Keywords
- 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.
Percutaneous coronary interventionDevice
Also called PRO-Kinetic stent system
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| BMS implantation | Experimental | Patients meeting the inclusion criteria and none of the exclusion criteria are treated by implanting the study device (the ProKinetic bare metal stent). Since it is a single arm study design, no patients are enrolled to a control arm. Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.
Measured: at 180 days post procedure
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE)
MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.
Measured: at 180 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Vermeersch, MD, PhD, Principal investigator, ZNA Middelheim, Department Interventional CardiologyMaarten J. Suttorp, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531725
- Sponsor's protocol ID
- C0601
- Acronym
- MULTIBENE
- Status last verified
- Mar 2013
- First submitted
- 9 Feb 2012
- Last updated
- 25 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vermeersch P, Appelman Y, Horstkotte D, Richardt G, Boland J, Lalmand J, Coussement P, Castadot M, Janssens L, Agostoni P, Buysschaert I, Suttorp MJ. Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study. Cardiovasc Revasc Med. 2012 Nov-Dec;13(6):316-20. doi: 10.1016/j.carrev.2012.09.006.
PubMed 23164477
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System
- ClinicalTrials.gov ID
- NCT01531725
- Acronym / sponsor ID
- MULTIBENE / C0601
- Conditions
- Coronary Artery Disease
- Keywords
- Stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Posted 19 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate safety and efficacy of the BIOTRONIK PRO-Kinetic coronary CoCr-stent in patients with single de novo lesions of native coronary arteries.
Detailed description
The PRO-Kinetic study is a multi-center, prospective, consecutive non-randomized study enrolling 200 patients with single de novo lesions in native coronary arteries meeting the entry criteria. Those who provide informed consent will be enrolled to receive the PRO-Kinetic stent. Telephone follow-up will be performed at 1 month for all enrolled patients. After 6 months 100 patients will have an angiographic follow-up and 100 patients will be checked by telephone again. Additionally, a clinical telephone follow-up will be performed in all patients after 12 months.
This study is designed to yield data on the clinical safety and efficacy of the PRO-Kinetic stent in the coronary artery application. The Target Vessel Failure Rate after 6 months shall be below 18 % (max. 35 Serious Adverse Events and Expedited Events) to show a safety/performance profile that could be considered in the range of the currently available bare metal stent systems
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS implantation | Experimental | Device: Percutaneous coronary interventionPatients meeting the inclusion criteria and none of the exclusion criteria are treated by implanting the study device (the ProKinetic bare metal stent). Since it is a single arm study design, no patients are enrolled to a control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient must be at least 18 years old.
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable (Canadian Cardiovascular Society Classification [CCS] 1, 2, 3, or 4) or unstable (Braunwald type I, II, III and A, B or C) angina pectoris, or documented silent ischemia.
- Left ventricular ejection fraction (LVEF) > 30% documented within the last 6 weeks.
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
Key exclusion criteria (25 listed)
- Planned treatment with any other PCI device in target vessel except the pre-dilatation balloon.
- MI within 72 hours prior to the index procedure and/or creatine kinase (CK) > 2 times the local laboratory upper limits of normal, measured on the day of the index procedure, associated with elevated MB.
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
- Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or > 150 µmol/L).
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 |
|---|---|---|
| Percutaneous coronary interventionAlso: PRO-Kinetic stent systemPercutaneous coronary intervention | Device | BMS implantation |
Primary outcome
Target Vessel Failure (TVF)
Time frame: at 180 days post procedure
Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.
1 secondary outcome
Major Adverse Cardiac Events (MACE)
Time frame: at 180 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23164477Vermeersch P, Appelman Y, Horstkotte D, Richardt G, Boland J, Lalmand J, Coussement P, Castadot M, Janssens L, Agostoni P, Buysschaert I, Suttorp MJ. Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study. Cardiovasc Revasc Med. 2012 Nov-Dec;13(6):316-20. doi: 10.1016/j.carrev.2012.09.006.
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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.
Paul Vermeersch, MD, PhD principal investigator
ZNA Middelheim, Department Interventional Cardiology
Maarten J. Suttorp, MD, PhD principal investigator
St. Antonius Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Coronary Artery Disease, run by Biotronik AG.
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 16 inclusion and 25 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 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 19 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Target Vessel Failure (TVF) (time frame: at 180 days post procedure). 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 NCT01531725, 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 25 Mar 2013.