MULTIcentric BElgium/NEtherlands PRO-Kinetic Safety and Efficacy Study

Study Overview
=================
Brief 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.

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

Official Title
-----------------
6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Percutaneous coronary intervention


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS implantation<br>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<br>* Percutaneous coronary intervention<br>* Other names: PRO-Kinetic stent system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death. | at 180 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting. | at 180 days post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stents