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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/NCT02470884
Registration number
NCT02470884
Ethics application status
Date submitted
10/06/2015
Date registered
12/06/2015
Date last updated
22/06/2022
Titles & IDs
Public title
FAST Feasibility Study
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Scientific title
Fully Absorbable Scaffold Feasibility Study
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Secondary ID [1]
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S2327
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Boston Scientific Fully Absorbable Scaffold
Experimental: FAST - Subjects treated with the Boston Scientific Fully Absorbable Scaffold
Treatment: Devices: Boston Scientific Fully Absorbable Scaffold
Attempt to implant the Boston Scientific Fully Absorbable Scaffold.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Procedural Success
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Assessment method [1]
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Percent diameter stenosis =30% and no in-hospital MACE (Death, MI or TLR)
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Timepoint [1]
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In-hospital (through discharge or 7 days from the index procedure, whichever is sooner)
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Secondary outcome [1]
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In-scaffold late loss
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Assessment method [1]
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angiographic endpoint
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Timepoint [1]
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6 months
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Eligibility
Key inclusion criteria
- Subject must be at least 18 years of age
- Subject (or legal guardian) understands the study requirements and the treatment
procedures and provides written informed consent before any study-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
- Target lesion must be <12 mm in length with reference vessel diameter >2.75 mm and
<3.25 mm
- Target lesion must have visually estimated stenosis >50% and <100% with thrombolysis
in Myocardial Infarction (TIMI) flow >1
- The target lesion must be successfully predilated Note: Successful predilatation
refers to dilatation with a balloon catheter of appropriate length and diameter with
=30% residual stenosis and no dissection greater than National Heart, Lung, Blood
Institute (NHLBI) type C.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute MI
- Subjects with unstable angina or recent MI (clinically diagnosed within the past 2
weeks) must have cardiac troponin (cTn) documented prior to the procedure and are
excluded if cTn is > 5x ULN
- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmias, or ongoing
intractable angina
- Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon
angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index
procedure
- Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent,
cutting balloon, atherectomy) within 1 year prior to the index procedure
- Planned PCI or CABG after the index procedure
- Subject has a known allergy to contrast that cannot be adequately premedicated or to
the study scaffold system or protocol-required concomitant medications (e.g.,
everolimus or structurally related compounds, polymer or individual components, all
P2Y12 inhibitors, or aspirin)
- 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
- Subject has a known condition(s) of the following (as assessed prior to the index
procedure):
- 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
- Subject previously treated at any time with intravascular brachytherapy
- 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 that is clinically significant,
including laboratory evidence of active hepatitis
- Subject is on dialysis or has baseline serum creatinine level >2.0mg/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., is NYHA class IV) at the
time of the index procedure
- Subject is participating in another investigational drug or device clinical study that
has not reached its primary endpoint
- Subject intends to participate in another investigational drug or device clinical
study within 12 months after the index procedure
- Subject is a woman of child-bearing potential 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)
- Planned treatment of more than 1 target lesion and 1 non-target lesion (see below
"Multiple Interventions During Index Procedure")
- Planned treatment of the target lesion with more than 1 scaffold
- Target lesion is located in the left main
- Target lesion is located within 3mm of the origin of the left anterior descending
(LAD) coronary artery, left circumflex (LCX) coronary artery or right coronary artery
(RCA)
- Target lesion is located within a saphenous vein graft or arterial graft or will be
accessed via a saphenous vein graft or an arterial graft
- Target lesion involves a side branch >2.0mm in diameter
- Target lesion involves a clinically significant side branch <2.0 mm in diameter that
has a clinically significant stenosis at the ostium.
- Target lesion and/or target vessel proximal to the target lesion is moderately to
severely calcified
- Excessive tortuosity or extreme angulation proximal to or within the target lesion
- Target lesion is restenotic from a previous stent implantation
- Thrombus, or possible thrombus, present in the target vessel
- 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)
- Restenotic from previous intervention
- Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/02/2022
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
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St. Vincent's Hospital - Fitzroy
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Recruitment hospital [3]
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Peninsula Health - Frankston
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Recruitment hospital [4]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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4032 - Chermside
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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3168 - Melbourne
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Recruitment outside Australia
Country [1]
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Latvia
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State/province [1]
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Riga
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A prospective multi-center, single arm feasibility study to assess the safety and performance
of the Boston Scientific Fully Absorbable Scaffold.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02470884
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sujth Seneviratne, MBBS
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Address
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MonashHeart, Southern Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02470884
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