Trial Review

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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
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
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Illinois
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Indiana
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Iowa
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United States of America
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Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
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United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
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Michigan
Country [19] 0 0
United States of America
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Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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Texas
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United States of America
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Virginia
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Washington
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United States of America
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Wisconsin
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Bonheiden
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Belgium
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Genk
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
State/province [42] 0 0
Alberta
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Copenhagen
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Finland
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Tampere
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Finland
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Turku
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France
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Finistere
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France
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Haute Garonne
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France
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Rhone
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France
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Seine Maritime
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France
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Var
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France
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Lagny-sur-Marne cedex
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France
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Paris
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Italy
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Milano
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Italy
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Roma
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Italy
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Torino
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Japan
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Fukuoka-Ken
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Japan
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Kanagawa-Ken
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Japan
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Kanagawa
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Japan
State/province [61] 0 0
Kyoto-Fu
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Japan
State/province [62] 0 0
Osaka-Fu
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Japan
State/province [63] 0 0
Tokyo-To
Country [64] 0 0
Latvia
State/province [64] 0 0
Riga
Country [65] 0 0
Netherlands
State/province [65] 0 0
Alkmaar
Country [66] 0 0
Netherlands
State/province [66] 0 0
Enschede
Country [67] 0 0
Netherlands
State/province [67] 0 0
Nieuwegein
Country [68] 0 0
New Zealand
State/province [68] 0 0
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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Poland
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Warszawa
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Singapore
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Singapore
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Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01665053