Trial Search Results

FAST Feasibility Study

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Boston Scientific Corporation

Stanford Investigator(s):

Intervention(s):

  • Device: Boston Scientific Fully Absorbable Scaffold

Phase:

N/A

Eligibility


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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting