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FAST Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470884
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Boston Scientific Fully Absorbable Scaffold Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fully Absorbable Scaffold Feasibility Study
Actual Study Start Date : June 15, 2015
Actual Primary Completion Date : January 31, 2017
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. In-scaffold late loss [ Time Frame: 6 months ]
    angiographic endpoint



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470884


Locations
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Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Peninsula Health
Frankston, Victoria, Australia, 3199
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Latvia
P. Stradins University Hospital
Riga, Latvia, LV-1002
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
North Shore Hospital
Takapuna, Auckland, New Zealand, 0622
Mercy Angiography Unit, Ltd.
Auckland, New Zealand, 1023
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Sujth Seneviratne, MBBS MonashHeart, Southern Health
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02470884    
Other Study ID Numbers: S2327
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases