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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01135225




Registration number
NCT01135225
Ethics application status
Date submitted
31/05/2010
Date registered
2/06/2010
Date last updated
3/02/2017

Titles & IDs
Public title
Non-inferiority Trial to Assess the Safety and Performance of the Evolution Coronary Stent
Scientific title
EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion
Secondary ID [1] 0 0
S2060
Universal Trial Number (UTN)
Trial acronym
Evolve
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(TM) Element (TM) Stent System
Treatment: Devices - Evolution Stent System

Active Comparator: PROMUS(TM) Element(TM) Coronary Stent - PROMUS(TM) Element(TM) Everolimus-Eluting Coronary Stent System

Experimental: Evolution Coronary Stent A - Evolution Everolimus-Eluting Monorail Coronary Stent System

Experimental: Evolution Coronary Stent B - Evolution Everolimus-Eluting Monorail Coronary Stent System


Treatment: Devices: PROMUS(TM) Element (TM) Stent System
The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.

Treatment: Devices: Evolution Stent System
The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite safety endpoint of Target Lesion Failure (TLF) at 30 days post-procedure
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
In-stent late loss at 6 month post-procedure
Timepoint [2] 0 0
6 months post-procedure
Secondary outcome [1] 0 0
Target lesion revascularization (TLR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [1] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [2] 0 0
Target vessel revascularization (TVR) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [2] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [3] 0 0
Target lesion failure (TLF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [3] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [4] 0 0
Target vessel failure (TVF) rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [4] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [5] 0 0
Cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [5] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [6] 0 0
Non-cardiac death rate at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [6] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [7] 0 0
MI rate (TV and overall)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [7] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Secondary outcome [8] 0 0
Stent thrombosis rate (by Academic Research Consortium [ARC] definition)at 30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years
Timepoint [8] 0 0
30 days, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years

Eligibility
Key inclusion criteria
- Patient must be at least 18 years of age

- Patient (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

- Patient is eligible for percutaneous coronary intervention (PCI)

- Patient has symptomatic coronary artery disease or documented silent ischemia

- Patient is an acceptable candidate for coronary artery bypass grafting (CABG)

- Patient has a left ventricular ejection fraction (LVEF) =30% as measured within 60
days prior to enrollment

- Patient is willing to comply with all protocol-required follow-up evaluations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute MI

- Patient with unstable angina or recent MI (within 72 hours) 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:

1. If CK MB >2× upper limit of normal (ULN), the patient is excluded regardless of
the CK Total.

2. If CK Total >2× ULN, either CK-MB or troponin must be drawn and the patient is
excluded if either CK-MB or troponin is abnormal.

3. If neither CK Total or CK MB is drawn but troponin is, the patient is excluded
if:

- Troponin >1× ULN and the patient has at least one of the following:

- Patient 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 Note: Patients with stable angina must have CK/CK-MB or
troponin drawn prior to the index procedure. However, the results for these
patients do not need to be available prior to the index procedure and there
are no exclusion criteria based on these studies.

- Patient has received an organ transplant or is on a waiting list for an organ
transplant

- Patient is receiving or scheduled to receive chemotherapy within 30 days before or
after the index procedure

- Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled
steroids are not excluded ) or has known life-limiting immunosuppressive or autoimmune
disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not
including diabetes mellitus)

- Patient is receiving chronic (=72 hours) anticoagulation therapy (e.g., heparin,
coumadin) for indications other than acute coronary syndrome

- Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3

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

- Patient has documented or suspected liver disease, including laboratory evidence of
hepatitis

- Patient is on dialysis or has known renal insufficiency (e.g. serum creatinine level
>2.0 mg/dL)

- Patient has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other
bleeding diathesis or coagulopathy, or will refuse transfusions

- Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA)
within the past 6 months, or has any permanent neurologic defect that may cause
non-compliance with the protocol

- Target vessel (including side branches) has been treated with any type of PCI (e.g.,
balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to
the index procedure

- Target vessel has been treated within 10 mm proximal or distal to the target lesion
(by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting
balloon, atherectomy) at any time prior to the index procedure

- Non-target vessel (including side branches) has been treated with any type of PCI
(e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior
to the index procedure Note: 1 lesion in a non-target vessel may be treated during the
index procedure prior to the treatment of the target (study) lesion. The treatment of
lesion(s) in non-target vessels more than 24 hours prior to the procedure does not
preclude the treatment of an additional non-target lesion during the index procedure.
For example, a patient could have an RCA lesion treated 7 days prior to the index
procedure and then have a non-target lesion in the LCx and a target lesion in the LAD
treated during the index procedure.

- Planned or actual target vessel treatment with an unapproved device, directional or
rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction
catheter immediately prior to stent placement

- Planned PCI or CABG after the index procedure

- Patient previously treated at any time with coronary intravascular brachytherapy

- Patient has a known allergy to the trial stent system or protocol-required concomitant
medications (e.g., stainless steel, platinum, chromium, nickel, tungsten, acrylic,
fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be
adequately premedicated

- Patient has one of the following.

- 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

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

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

- Patient 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.)

- Patient 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.)

- Patient has more than 1 target lesion and 1 non-target lesion that will be treated
during the index procedure

Angiographic Inclusion criteria (Visual Estimate):

- Target lesion must be a de novo lesion located in a native coronary artery with a
visually estimated reference vessel diameter (RVD) = 2.25 mm and =3.5 mm.

- Target lesion length must be = 28 mm (by visual estimate)

- Target lesion must have visually estimated stenosis =50% and <100% with Thrombolysis
in Myocardial Infarction (TIMI) flow >1.

- Target lesion must be successfully pre-dilatated.

Angiographic Exclusion criteria (visual estimate):

- Target lesion meets any of the following criteria.

- Left main location

- Located within 5 mm of the origin of the left anterior descending (LAD), left
circumflex (LCX) or RCA by visual estimate

- Located within a saphenous vein graft or an arterial graft

- Will be accessed via a saphenous vein graft or arterial graft

- Involves a side branch =2.0 mm in diameter by visual estimate

- Involves a side branch <2.0 mm in diameter by visual estimate which requires
treatment

- TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing

- Excessive tortuosity proximal to or within the lesion

- Excessive angulation proximal to or within the lesion

- Target lesion and/or target vessel proximal to the target lesion is moderately to
severely calcified by visual estimate

- Restenotic from previous intervention

- Thrombus, or possible thrombus, present in the target vessel

- Target lesion cannot be covered by a single study stent

- Patient has unprotected left main coronary artery disease (>50% diameter stenosis)

- Patient has protected left main coronary artery disease and a target lesion in the LAD
or LCX

- Patient has an additional clinically significant lesion(s) in the target vessel for
which an intervention within 12 months after the index procedure may be required

- Non-target lesion to be treated during the index procedure meets any of the following
criteria.

- Located within the target vessel

- Located within a bypass graft (venous or arterial)

- Left main location

- Chronic total occlusion

- Involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with
more than 1 stent)

- Requires additional unplanned stents

- Treatment not deemed a clinical angiographic success

- Treatment not completed prior to treatment of target lesion

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
Not Applicable
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
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
291
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Monash Medical Centre - 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
QLD 4032 - Chermside
Recruitment postcode(s) [2] 0 0
VIC 3168 - Clayton
Recruitment postcode(s) [3] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
Denmark
State/province [6] 0 0
Århus
Country [7] 0 0
France
State/province [7] 0 0
Ollioules
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
New Zealand
State/province [10] 0 0
Dunedin
Country [11] 0 0
New Zealand
State/province [11] 0 0
Otahuhu
Country [12] 0 0
New Zealand
State/province [12] 0 0
Takapuna
Country [13] 0 0
Poland
State/province [13] 0 0
Bydgoszcz
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
El Palmar
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Sweden
State/province [17] 0 0
Falun
Country [18] 0 0
Sweden
State/province [18] 0 0
Uppsala
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Belfast
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Cambridge
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Clydebank
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Liverpool
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Oxford

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 the EVOLVE Trial is to assess the safety and performance of the
everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of
up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety
and performance of two different drug release rate formulations of the Evolution Stent will
be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01135225
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, Prof
Address 0 0
Monash Medical Centre
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/ct2/show/NCT01135225