The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Device: SYNERGY; Device: PROMUS Element Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665053

G120123 (Other Identifier)

S2067

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Full description

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Enrollment: 1,684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must be at least 18 years of age
• 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
• For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject is willing to comply with all protocol-required follow-up evaluation

Angiographic Inclusion Criteria (visual estimate):

• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
• Target lesion(s) length must be ≤34 mm (by visual estimate)
• 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
• Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• The first lesion treated must be successfully predilated/pretreated

Exclusion criteria

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)

• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina

• Subject has received an organ transplant or is on a waiting list for an organ transplant

• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure

• Planned PCI (including staged procedures) or CABG after the index procedure

• Subject previously treated at any time with intravascular brachytherapy

  _ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or 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, all P2Y12 inhibitors, or aspirin)

• Subject has one of the following (as assessed prior to the index procedure):

  • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of 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

• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome

• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3

• Subject has a white blood cell (WBC) count < 3,000 cells/mm3

• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

• Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)

• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

• Subject has severe symptomatic heart failure (i.e., NYHA class IV)

• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint

• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure

• 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)

• 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)

Angiographic Exclusion Criteria (visual estimate):

• Planned treatment of more than 3 lesions
• Planned treatment of lesions in more than 2 major epicardial vessels
• Planned treatment of a single lesion with more than 1 stent
• Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
• Target lesion(s) is located in the left main
• Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
• Target lesion(s) is located within a saphenous vein graft or an arterial graft
• Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
• Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
• Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,684 participants in 2 patient groups

Promus Element Plus

Active Comparator group

Description:

PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).

Treatment:

Device: PROMUS Element Plus

SYNERGY

Experimental group

Description:

SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).

Treatment:

Device: SYNERGY