The EVOLVE China Clinical Trial (EVOLVE-CHINA)

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

• CI1. Subject must be 18 -75 years of age
• CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
• CI3. Subject is eligible for percutaneous coronary intervention (PCI)
• CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• CI6. Subject is willing to comply with all protocol-required follow-up evaluation
• CI7. Subject has a left ventricular ejection fraction (LVEF) >30% as measured within 60 days prior to enrollment
• AI1. Target lesion(s) must be de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
• AI2. Target lesion(s) length must be ≤34 mm (by visual estimate)
• AI3. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following: stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• AI5. The first lesion treated must be successfully predilated/pretreated

Exclusion Criteria:

• CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI .

• CE2. Subject with unstable angina or recent MI (within 1 week) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:

  • If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
  • If CK Total >2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal.

  • If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin >1× ULN and the subject has at least one of the following:

    • Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB])
    • Development of pathological Q waves in the ECG or
    • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
• CE3. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, or intractable ventricular arrhythmias or ongoing intractable angina
• CE4. Subject has received an organ transplant or is on a waiting list for an organ transplant
• CE5. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• CE6. Planned PCI or CABG after the index procedure
• CE7. Subject has a known allergy to the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, clopidogrel, or aspirin) and contrast (that cannot be adequately premedicated)

• CE8. Subject has a known condition(s) of the following (as assessed from the time of screening through the day of index procedure):

  • Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
  • Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
  • Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, Coumadin) for indications other than acute coronary syndrome
• CE10. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
• CE11. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• CE12. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
• CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• CE14. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
• CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
• CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
• CE17. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• CE18. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• CE19. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
• CE20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
• CE21. Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
• AE1. Planned treatment of more than 2 lesions
• AE2. Planned treatment of lesions in more than 2 major epicardial vessels
• AE3. Planned treatment of a single lesion with more than 1 stent Note: Planned use of 2 overlapping stents will be allowed in subjects randomized to PROMUS Element Plus where lesion length is ≥28 mm and 2.25 mm stents are used.

• AE4. Target lesion meets any of the following criteria:

  • Left main location
  • Located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
  • Located within a saphenous vein graft or an arterial graft
  • Will be accessed via a saphenous vein graft or an arterial graft
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Thrombus, or possible thrombus, present in the target vessel
  • Excessive tortuosity proximal to or within the lesion
  • Excessive angulation proximal to or within the lesion
  • Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
  • Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch <2.0 mm in diameter by visual estimate which requires treatment
• AE5. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• AE6. Target lesion(s) is restenostic from a previous stent implantation or study stent would overlap with a previous stent
• AE7. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
• AE8. Subject has protected left main coronary artery disease (>50% diameter stenosis in the LMCA with bypass graft(s) to the left coronary artery) and a target lesion in the LAD or LCX