Coronary Artery Disease
Conditions
Keywords
Stents
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
Interventions
DEVICEPercutaneous coronary intervention
Percutaneous coronary intervention
Sponsors
Biotronik AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | at 180 days post procedure | Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | at 180 days post procedure | MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting. |
Participant flow
Recruitment details
202 patients at 10 European sites have been enrolled.
Pre-assignment details
Not group assignment.
Participants by arm
| Arm | Count |
|---|---|
| BMS Implantation Patients with a BMS implanted. | 197 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | BMS Implantation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 100 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants |
| Age Continuous | 64.2 years STANDARD_DEVIATION 11 |
| Region of Enrollment Belgium | 83 participants |
| Region of Enrollment Germany | 38 participants |
| Region of Enrollment Netherlands | 76 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 179 |
| serious Total, serious adverse events | 29 / 179 |
Outcome results
Primary
Target Vessel Failure (TVF)
Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.
Time frame: at 180 days post procedure
Population: Patients with follow up data available either 180 or 360 days post procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS Implantation | Target Vessel Failure (TVF) | 20 participants |
Secondary
Major Adverse Cardiac Events (MACE)
MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.
Time frame: at 180 days post procedure
Population: Patients with follow up available either 180 or 360 days post procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS Implantation | Major Adverse Cardiac Events (MACE) | 21 participants |