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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01665053




Registration number
NCT01665053
Ethics application status
Date submitted
7/08/2012
Date registered
15/08/2012
Date last updated
30/01/2019

Titles & IDs
Public title
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
Scientific 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)
Secondary ID [1] 0 0
G120123
Secondary ID [2] 0 0
S2067
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - PROMUS Element Plus
Treatment: Devices - SYNERGY

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).

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).


Treatment: Devices: PROMUS Element Plus
A drug eluting coronary stent system

Treatment: Devices: SYNERGY
A drug eluting coronary stent system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Percentage of Participants With Myocardial Infarction at 12 Month.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Percentage of Participants With Cardiac Death at 12 Month.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Percentage of Participants With Non-Cardiac Death at 12 Month.
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Percentage of Patients That Died at 12 Months.
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Percentage of Patients With a Stroke at 12 Month.
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Periprocedural Technical Success Rate.
Timepoint [13] 0 0
Day 1 (periprocedure)
Secondary outcome [14] 0 0
Periprocedural Clinical Procedural Success Rate
Timepoint [14] 0 0
Day 1 (periprocedure)
Secondary outcome [15] 0 0
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
Timepoint [15] 0 0
12 month
Secondary outcome [16] 0 0
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
Timepoint [16] 0 0
12 Month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/12/2018
Sample size
Target
Accrual to date
Final
1684
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Monash Medical Centre-Clayton Campus - Clayton
Recruitment hospital [3] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [4] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Maryland
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Massachusetts
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Mississippi
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Missouri
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Austria
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Salzburg
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Bonheiden
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Leuven
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Copenhagen
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Tampere
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Turku
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France
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Finistere
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France
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Var
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Torino
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Fukuoka-Ken
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Kanagawa
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Kyoto-Fu
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Osaka-Fu
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Japan
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Tokyo-To
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Latvia
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Riga
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Netherlands
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Alkmaar
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Netherlands
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Enschede
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Netherlands
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Nieuwegein
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Poland
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Krakow
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Poland
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Poznan
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Warszawa
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT01665053
Trial related presentations / publications
Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.
Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.
Public notes

Contacts
Principal investigator
Name 0 0
Peter M Maurer, MPH
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01665053