Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Cad
• Age: Between 18 years - 120 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Participants experiencing clinical symptoms considered suggestive of ischemic heart disease
  2. Participants who are eligible and consents to undergo PCI procedure
  3. Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency CABG
  4. Participants will provide a written informed consent form
  5. Female child bearing potential participants must have a negative pregnancy test and use contraception
  6. Participants with minimum of one de novo lesion with at least one target segment in a native coronary vessel meeting the definition of CTO

  
  

You may not be eligible for this study if the following are true:

• 1. History of allergy to iodinated contrast that cannot be effectively managed medically
  2. Participants who have had an acute myocardial infarction (MI) within 72 hours prior
  3. Participants who had a previous coronary interventional procedure of any kind within 30 days prior to the procedure
  4. Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI
  5. Target lesion requires treatment with another device, after successful crossing with a study device, other than PTCA devices prior to stent placement
  6. Atherectomy procedure is planned for the target lesion
  7. Known history of clinically significant abnormal laboratory findings = 14 days prior to enrollment
  8. Participants with evidence of current clinical instability
  9. History of stroke or transient ischemic attack within 6 months prior to procedure
  10. Participants with active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
  11. History of bleeding diathesis or coagulopathy or refusal of blood transfusions
  12. Other pathology such as cancer, known mental illness, etc., which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study
  13. Unable or unwilling to comply with the protocol
  14. Currently participating in an investigational drug or device study
  15. Occlusion involves segment within previous stent
  16. Extensive lesion-related thrombus
  17. Target vessel has other lesions proximal to the total occlusion