MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study (MULTIBENE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01531725
First received: February 9, 2012
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Target Vessel Failure (TVF) [ Time Frame: at 180 days post procedure ] [ Designated as safety issue: Yes ]
    Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.


Secondary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) [ Time Frame: at 180 days post procedure ] [ Designated as safety issue: Yes ]
    MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.


Enrollment: 202
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS implantation
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.
Device: Percutaneous coronary intervention
Percutaneous coronary intervention
Other Name: PRO-Kinetic stent system

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531725

Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Paul Vermeersch, MD, PhD ZNA Middelheim, Department Interventional Cardiology
Principal Investigator: Maarten J. Suttorp, MD, PhD St Antonius Hospital Nieuwegein
  More Information

Publications:
Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01531725     History of Changes
Other Study ID Numbers: C0601
Study First Received: February 9, 2012
Results First Received: February 14, 2013
Last Updated: March 19, 2013
Health Authority: Belgium: Ethics Committee
Netherlands: Independent Ethics Committee
Germany: Ethics Commission

Keywords provided by Biotronik AG:
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014