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

Biotronik

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous coronary intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT01531725

C0601

Details and patient eligibility

About

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.

Full 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

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 1 patient group

BMS implantation

Experimental group

Description:

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.

Treatment:

Device: Percutaneous coronary intervention