A Non-Randomized Study Evaluating the CapBuster System Medical Device for the Crossing of CTO's in Coronary Arteries

Evaluate the safety and effectiveness of the CapBuster System medical device in crossing de novo or restenotic chronic total occlusions in coronary arteries

Inclusion Criteria:Males > 18 years of age and Female patients of non child-bearing potentialClinical diagnosis of coronary arterial disease requiring revascularization as evidenced by Duplex UltraSound, Digital Subtraction Angiography, CT angiography, or MR angiographySubject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).Subject's lesion(s) is (are) amenable to stent treatment with currently available CE or FDA-approved stents.Presence of coronary arterial de novo or restenotic chronic total occlusion (100% stenosis), with TIMI 0 flow, confirmed by angiography. Vessel distal to the occlusion(s) must be visualized per collateral or retrograde flow. A maximum of 1 target occlusions can be treated per patient. Target occlusion(s) can be in-stent restenosisTarget vessel(s) must be ≥ 2.5 mm and ≤ 3.25 mm in diameter proximal to the target occlusion(s) by visual estimateIn the opinion of the investigator, life expectancy of > 1 yearWilling and able to sign the informed consent formExclusion Criteria:Target occlusion is within a bypass graftacute coronary syndrome with ST elevation,cardiogenic shock or out of hospital cardiac arrestSubject has signs or symptoms of systemic infection/sepsis (temperature ≥38.0o Celsius and WBC ≥12,000 cells/uL). If subject has localized infection, including cellulitis or osteomyelitis, or infection is adequately treated and controlled, per investigator discretion, patient may be enrolled.Known or suspected myocardial infarction or stroke within previous 30 daysCurrently participating in another investigational drug or device studyFemale patients of child-bearing potential.Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.Cardiogenic shock on presentation or during current hospitalization.Known allergies or contraindication to: contrast materials, antiplatelet therapy, aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).Stroke or transient ischemic attack within the prior 3 months.Any target vessel that has evidence of excessive thrombus (e.g. requires target vessel thrombectomy).Any target vessel that has evidence of excessive tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,Any target lesion that requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).