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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Fully Absorbable Scaffold Feasibility Study
Secondary ID [1] 0 0
S2327
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 - 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Procedural Success
Timepoint [1] 0 0
In-hospital (through discharge or 7 days from the index procedure, whichever is sooner)
Secondary outcome [1] 0 0
In-scaffold late loss
Timepoint [1] 0 0
6 months

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.
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 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
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
15/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2022
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
Peninsula Health - Frankston
Recruitment hospital [4] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Latvia
State/province [1] 0 0
Riga
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
A prospective multi-center, single arm feasibility study to assess the safety and performance of the Boston Scientific Fully Absorbable Scaffold.
Trial website
https://clinicaltrials.gov/study/NCT02470884
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sujth Seneviratne, MBBS
Address 0 0
MonashHeart, Southern Health
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/NCT02470884