Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of the Long-term Effects on Mortality and Cardiovascular Morbidity of Percutaneous Coronary Intervention With Drug-eluting Stent Versus Bare-metal Stent. Randomized, Five-year Prospective, Multicenter Clinical Trial
Brief Summary: Stenosis of the coronary arteries may be treated by balloon dilatation followed by the implantation of a metal stent. However, restenosis occurs in 10-20% of patients treated with bare metal stents (BMS). Restenosis and treatment of restenosis is associated with risk of myocardial infarction (MI) and death. Drug eluting stents (DES)release drugs to the vessel wall that delay or inhibit the process of restenosis. Some reports have found that DES are associated with risk of acute stent thrombosis, MI and death. The precise magnitude of this risk is not known. Current evidence is therefore insufficient to balance the long-term risk and benefit of BMS vs DES.

The purpose of this trial is to compare the long-term effects on MI and total mortality of BMS vs DES. The trial will recruit 8000 patients from 8 Norwegian hospitals. The patients will be randomized to treatment with BMS or DES. Clinical events will be registered for 5 years after treatment. The study hypothesis is that there is no difference in the risk of death or myocardial infarction after treatment with BMS vs DES. The trial is initiated and run by university researchers and is sponsored by not-for-profit organizations.


Options:
A: Inclusion Criteria:

* Subject is \> 18 years and \< 80 years of age
* Written subject informed consent available prior to PCI
* Subjects with stable or unstable angina pectoris or documented silent ischemia
* Subject eligible for PCI
* Subject acceptable candidate for coronary artery bypass surgery
* Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
* Reference vessel diameter between 2.2-3.8 mm by visual estimation
* Target lesion length ≤ 21 mm by visual estimation
* Target lesion stenosis by visual estimation, assisted by QCA / IVUS: \> 50% - \< 100%
* Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion Criteria:

* Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
* Evidence of myocardial infarction within 72 hours prior to index procedure
* Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
* Unprotected left main coronary artery disease
* Three-vessel coronary artery disease at time of procedure
* Thrombus in target vessel
* Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
* Planned interventional treatment of any non-target vessel within 30 days post-procedure
* Subjects on dialysis
* Planned intervention of the target vessel within 6-month after the index procedure
* Ostial target lesion (within 5.0 mm of vessel origin)
* Target lesion involves a side branch \>2.0 mm in diameter
* Documented left ventricular ejection fraction (LVEF) ≤ 30%
* Heavily calcified lesion
* Target lesion is located in or supplied by an arterial or venous bypass graft
* The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
* Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
* Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
* Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
* Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
* Life expectancy less than 1 year
* Planned surgery or dental surgical procedure within 6 months after index procedure
* In the investigators opinion subjects will not be able to comply with the follow-up requirements
B: Inclusion Criteria:

* Men and women \>18 years with stable angina pectoris or acute coronary syndrome
* The patient has consented to participate and has signed the patient informed consent form
* All lesions requiring intervention in one or more native coronary artery/coronary artery by-pass graft are amendable for implantation of drug-eluting stents only, or bare-metal stents only.
* The patient has a unique 11-digit Norwegian person number, is able to communicate in Norwegian, and is expected not to emigrate during study follow-up.

Exclusion Criteria:

* Previous implantation of a coronary bare metal stent or coronary drug eluting stent
* Planned intervention of a bifurcation lesion with overlapping 2-stent technique
* The patient has a serious medical condition (other than coronary artery disease) with a life expectancy less than 5 years
* The patient is currently participating in another randomized trial that clinically interferes with the present trial, or requires coronary angiography or other coronary artery imaging procedures
* Hypersensitivity or allergies to drugs or components in use with percutaneous coronary intervention
* Contraindications for treatment with clopidogrel/ticlid for 9-12 months
* Patient is receiving chronic anticoagulation therapy (e.g., warfarin, heparin)
C: Inclusion Criteria:

* Age equal or more than 18 years
* Chest pain \> 10 minutes
* Primary pci
* ST-segment elevation of \> 1 mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \> 1 mm in \> 2 contiguous anterior leads
* Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25-4 mm in diameter that can be covered with 1-multiple stents

Exclusion Criteria:

* Female of childbearing potential (age 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, biolimus or contrast material
* Inability to provide informed consent
* Currently participating in another trial before reaching first endpoint
* Mechanical complication of acute myocardial infarction
* Acute myocardial infarction secondary to stent thrombosis
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
* Noncardiac comorbid conditions are present with life expectancy 1 year or that may result in protocol malcompliance
* History of bleeding diathesis or known coagulopathy
* Use of Coumadin
* Additional for Imaging Substudy:

  * Age \> 90 years
  * Hemodynamic instability
  * Renal failure
  * OCT/IVUS technically not feasible
  * Any patient in whom angiography demonstrates the infarct lesion to be at the site of a previously implanted stent
D: Inclusion Criteria:

* written informed concent
* need for large (≥3.0 mm stents only) native vessel stenting

Exclusion Criteria:

* in-Stent Restenosis or in-Stent Thrombosis
* bypass graft disease to be stented
* main stem disease to be stented
* cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
* planned surgery within the next 12 months
* oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
* active bleeding disorders
* index-PCI = planned PCI of additional lesion
* no follow-up (FU) expected/possible
* History of stroke or TIA (contraindication for prasugrel)
* known severe hypersensitivity reaction to ASS and/or Prasugrel
* no compliance expected / no informed consent given
* enrolled in another study

Answer: B