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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03350542




Registration number
NCT03350542
Ethics application status
Date submitted
17/11/2017
Date registered
22/11/2017
Date last updated
4/04/2019

Titles & IDs
Public title
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
Scientific title
EVOLVE 48: A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of the SYNERGY 48 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)
Secondary ID [1] 0 0
S2356
Universal Trial Number (UTN)
Trial acronym
EVOLVE48
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
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SYNERGY 48 mm

Experimental: SYNERGY 48 mm - SYNERGY 48 mm 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: SYNERGY 48 mm
A drug eluting coronary stent system

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target Lesion Failure Rate - The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Timepoint [1] 0 0
12-month

Eligibility
Key inclusion criteria
Clinical 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

- Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable
candidate for coronary artery bypass grafting (CABG)

- Subject has either:

- Symptomatic coronary artery disease with one of the following: stenosis = 70%,
abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test,
or elevated biomarkers prior to the procedure

- OR

- Documented silent ischemia based on one of the following: abnormal fractional
flow reserve (FFR), abnormal stress or imaging stress test, or elevated
biomarkers prior to the procedure

- Subject is willing to comply with all protocol-required follow-up evaluation
Angiographic Inclusion Criteria (visual estimate)

- Target lesion must be located in a native coronary artery with a visually estimated
reference vessel diameter (RVD) =2.5 mm and =4.0 mm

- Target lesion length must be >34 mm and =44 mm (by visual estimate)

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

- Coronary anatomy is likely to allow delivery of a study device to the target lesion

- The target lesion must be successfully predilated/pretreated. If a non-target lesion
is treated, it should be treated first and should be deemed an angiographic success
Note: Angiographic success is a mean lesion diameter stenosis < 50% (< 30% for stents)
in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the
physician, without the occurrence of prolonged chest pain or ECG changes consistent
with MI.

Note: Successful predilatation/pretreatment refers to dilatation with a balloon catheter of
appropriate length and diameter, or pretreatment with directional or rotational coronary
atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis
and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

Clinical
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 enrollment):

- 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 signs or symptoms of active heart failure (i.e., NYHA class IV) at the
time of the index procedure

- 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 Angiographic Exclusion Criteria (visual
estimate)

- Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target
lesion, which will be treated during the index procedure Note: Multiple focal stenoses
will be considered as a single lesion if they can be completely covered with 1 study
stent

- Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in
the target vessel and 1 non-target lesion in non-target vessel is allowed

- 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)

- Target lesion meets any of the following criteria:

- Treatment of a single lesion with more than 1 stent

- Left main location

- Lesion 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

- Lesion is located within a saphenous vein graft or an arterial graft

- Lesion will be accessed via a saphenous vein graft or arterial graft

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

- Lesion treated during the index procedure that involves a complex bifurcation (e.g.,
bifurcation lesion requiring treatment with more than 1 stent)

- Lesion is restenotic from a previous stent implantation or study stent would overlap
with a previous stent

- Non-target lesion meets any of the following criteria:

- Located within the target vessel

- Left main location

- Lesion is located within a saphenous vein graft or an arterial graft

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

- Lesion treated during the index procedure that involves a complex bifurcation (e.g.,
bifurcation lesion requiring treatment with more than 1 stent)

- Requires additional unplanned stents (treatment of the non-target lesion with more
than one stent is permitted as long as the stents are initially planned)

- Treatment not deemed an angiographic success Note: Angiographic success is a mean
lesion diameter stenosis < 50% (< 30% for stents) in 2 near-orthogonal projections
with TIMI 3 flow, as visually assessed by the physician, without the occurrence of
prolonged chest pain or ECG changes consistent with MI.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Latvia
State/province [8] 0 0
Riga
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Takapuna
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Belfast
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Glasgow
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Newcastle Upon Tyne
Country [14] 0 0
United Kingdom
State/province [14] 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
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this
study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm
Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm
and = 44 mm in length (by visual estimate) in native coronary arteries =2.5 mm to =4.0 mm in
diameter (by visual estimate).
Trial website
https://clinicaltrials.gov/show/NCT03350542
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dimitrios Karmpaliotis, MD
Address 0 0
New York Presbyterian Hospital
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
Other publications