Please select the eligibility criteria that correspond to the clinical trial below.
Title: BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II
Brief Summary: BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).


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:

A) low restenosis risk based on angiographic findings defined as follows:

----patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft

B) high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:

1. Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
2. Recent (within previous 12 months) bleeding episode(s) which required medical attention
3. Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
4. Age greater than 80
5. Systemic conditions associated to increased bleeding risk (e.g. hematological disorders or any known coagulopathy determining bleeding diathesis, including history of or current thrombocytopenia defined as platelet count \<100,000/mm3 (\<100 x 109/L).
6. Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
7. Need for chronic treatment with steroids or NSAID

C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:

1. Allergy/intolerance to aspirin
2. Allergy/intolerance to clopidogrel AND ticlopidine
3. Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
4. patient with cancers (other than skin) and life expectancy \>1 year
5. Patients with systemic conditions associated with thrombosis diathesis (e.g., hematologic disorders and any known systemic conditions determining a pro-thrombotic state including immunological disorders)

   -

   Exclusion Criteria:
   * Any of the following:

     1. Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
     2. Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
     3. PCI with stenting in the previous 6 months
D: 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

Answer: A