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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01665053
First received: August 7, 2012
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: PROMUS Element Plus
Device: SYNERGY
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) Rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.


Secondary Outcome Measures:
  • Target Lesion Revascularization (TLR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • Target Lesion Failure (TLF) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • All Revascularization Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: No ]
  • Target Vessel Failure (TVF) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI, Q-wave and non-Q-wave) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Non-Cardiac Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death or Myocardial Infarction (MI) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death or Myocardial Infarction (MI) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • All Death, Myocardial Infarction (MI) or Target Vessel Revascularization (TVR) Rate [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Stent Thrombosis Rate by Academic Research Consortium (ARC) Definition [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Stroke Rate (ischemic and hemorrhagic) [ Time Frame: 30 days, 6 months, 12 months, 18 months, 2-5 years ] [ Designated as safety issue: Yes ]
  • Technical Success Rate [ Time Frame: Day 1 (periprocedure) ] [ Designated as safety issue: No ]
  • Clinical Procedural Success Rate [ Time Frame: Day 1 (periprocedure) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2009
Study Start Date: November 2012
Estimated Study Completion Date: August 2018
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Promus Element Plus
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).
Device: PROMUS Element Plus
Experimental: SYNERGY
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).
Device: SYNERGY

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665053

  Show 126 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Peter M Maurer, MPH Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01665053     History of Changes
Other Study ID Numbers: S2067, G120123
Study First Received: August 7, 2012
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Drug-Eluting Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014