Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries

The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES
reduces the rate of restenosis int he main branch (5-10%); however, results int he side
branch are not optimal. A study of T stenting in true bifurcation lesions showed a restenosis
rate int he main branch of approximately 6% using the CYPHER stent. However, the same study
demonstrated that the restenosis rate remained high int he side branch (20%) despite stent
implantation and when restenosis occurs, it is generally located at the ostium of the side
branch. Further, in half the cases where PTCA alone was the intended strategy for the side
branch, a side branch stent had to be placed to address sub-optimal procedural results.

These findings are consistent with previous metal stent studies and suggest the best
long-term results are obtained when a side branch stent is not placed. This study and others
suggest that the outcomes are related to the way the stents sit within in the vessel; and
therefore a stent designed specifically for bifurcation lesions will be needed to reduce
restenosis rates and improve long-term outcomes.

Inclusion Criteria:

- The patient must be ≥18 and ≤ 90 years of age;

- Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC,
IIIB, IIIC, and/or have objective evidence of myocardial ischemia);

- Acceptable candidate for CABG;

- Intent to treat the side branch of the target bifurcation based on angiographic
evaluation;

- The patient is willing to comply with specified follow-up evaluations;

- The patient or legally authorized representative has been informed of the nature of
the study, agrees to its provisions and has been provided written informed consent,
approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review
Board (IRB).

- Planned use of one of the following approved and commercially available drug-eluting
stents for subject's index procedure: CYPHER®, ENDEAVOR® RESOLUTE, PROMUS® or PROMUS®
ELEMENT, XIENCE™ V or XIENCE PRIME.

General Exclusion Criteria

- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year
following index procedure. Female patients of child-bearing potential must have a
negative pregnancy test done within 7 days prior to the index procedure per site
standard test;

- Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72
hours preceding the index procedure or >72 hours preceding the index procedure and CK
and CK-MB have not returned to within normal limits at the time of procedure;

- Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB
elevation;

- Patients with non-target lesion PCI within 7 days prior to index procedure with
continued CK-MB elevation;

- Impaired renal function (serum creatinine >2.5 mg/dL or 221 μmol/l) or on dialysis;

- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3;

- Patient has a history of bleeding diathesis or coagulopathy or patients in whom
anti-platelet and/or anticoagulant therapy is contraindicated, or any other
significant medical condition which in the Investigator's opinion may interfere with
the patient's optimal participation in the study;

- Patient has received an organ transplant or is on a waiting list for any organ
transplant;

- Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart
failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may
cause non-compliance with the protocol, confound the data interpretation or is
associated with a limited life expectancy (i.e., less than 1 year);

- Patient has a known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy,
cobalt-chromium alloy, rapamycin, everolimus, zotarolimus, paclitaxel, and/or contrast
sensitivity that cannot be adequately pre-medicated;

- Patient presents with cardiogenic shock or cardiac arrhythmias that create hemodynamic
instability;

- Patient in whom a surgical or other procedure is planned within the next year which
would require discontinuation of dual antiplatelet therapy;

- Currently participating in another investigational drug or device study or patient
inclusion in another investigational drug or device study where the primary endpoint
of the study has not been reached.