FAST Feasibility Study

June 16, 2022 updated by: Boston Scientific Corporation

Fully Absorbable Scaffold Feasibility Study

A prospective multi-center, single arm feasibility study to assess the safety and performance of the Boston Scientific Fully Absorbable Scaffold.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Boston Scientific Fully Absorbable Scaffold is a device/drug combination product providing a mechanical structure for vascular lumen support (the scaffold component) and a pharmacological agent (everolimus) targeted toward reducing the injury response that leads to restenosis after scaffold implantation.

The Boston Scientific Fully Absorbable Scaffold is intended to improve the luminal diameter in subjects with ischemic heart disease due to de novo native coronary artery target lesions ≤ 12 mm in length with reference vessel diameter ≥ 2.75 mm and ≤ 3.25 mm.

Subjects who are candidates for PCI for the treatment of a de novo native coronary artery lesion will be screened according to the protocol inclusion and exclusion criteria. Subjects will be considered enrolled once they have signed the informed consent form and an attempt has been made to implant the fully absorbable study scaffold.

During the index procedure 1 target lesion in a de novo native coronary artery may be treated. Up to 1 non-target lesion in a separate epicardial vessel may be treated with a commercially approved DES

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre
  • Latvia
      • Riga, Latvia, LV-1002
        • P. Stradins University Hospital
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FAST
Subjects treated with the Boston Scientific Fully Absorbable Scaffold
Device: Boston Scientific Fully Absorbable Scaffold
Attempt to implant the Boston Scientific Fully Absorbable Scaffold.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Procedural Success
Time Frame: In-hospital (through discharge or 7 days from the index procedure, whichever is sooner)
Percent diameter stenosis ≤30% and no in-hospital MACE (Death, MI or TLR)
In-hospital (through discharge or 7 days from the index procedure, whichever is sooner)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-scaffold late loss
Time Frame: 6 months
angiographic endpoint
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sujth Seneviratne, MBBS, MonashHeart, Southern Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S2327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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