ST Monitoring to Detect ACS Events in ICD Patients
This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this
study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the
Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St
Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the
device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect
clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by
demonstrating a low percentage of patients with false positive events.
Active, not recruiting | Atherosclerosis | Multisite
Nattokinase Atherothrombotic Prevention Study
Objectives and Hypotheses: The goal of the proposed study is to determine under randomized
controlled trial (RCT) conditions whether nattokinase reduces subclinical atherosclerosis
and cognitive decline in healthy women and men. The investigators' hypotheses are: 1)
Compared to placebo, nattokinase will show less subclinical atherosclerosis progression and
cognitive decline in healthy women and men; 2) The reduction in subclinical atherosclerosis
progression and cognitive decline with nattokinase will be correlated; and, 3) The reduction
in progression of subclinical atherosclerosis and cognitive decline with nattokinase will be
mediated through hemostatic, fibrinolytic and hemorheological factors as well as attenuation
of inflammation, monocyte activation, vascular endothelium injury and activation of vascular
endothelium by circulating monocytes.
Specific Aims: To conduct a RCT to determine the effect of nattokinase on the progression of
subclinical atherosclerosis (primary trial end point) and cognitive decline (secondary trial
end point). Healthy non-demented women and men >55 years old without pre-existing
symptomatic CVD and diabetes mellitus will be randomized over a 2 year period to oral
nattokinase (2,000 fibrinolysis units) daily versus placebo in this double-blind,
placebo-controlled trial; randomized treatment will be 3-years. The following 5 major
specific aims will be completed:
1. To determine the effect of nattokinase on the progression of subclinical carotid artery
atherosclerosis determined as the rate of change of the common carotid artery
intima-media thickness (CIMT) and arterial stiffness in computer image processed B-mode
2. To determine the effect of nattokinase on cognitive decline determined with a
neuropsychological battery designed to evaluate 7 cognitive domains including:
attention, concentration, working memory, executive function;
visuospatial/visuoconstructive skills; naming/semantic memory; and verbal and nonverbal
2a. To determine the effect of nattokinase on cognitive decline according to apolipoprotein
(Apo) E e4 genotype.
3. To determine the association of subclinical atherosclerosis progression with cognitive
4. To determine whether the effects of nattokinase on subclinical atherosclerosis and
cognitive decline are mediated through hemostatic (fibrinogen, factor VIII, platelet
activity), fibrinolytic (tPA, PAI-1, D-dimer), hemorheological (plasma and blood viscosity,
red blood cell aggregation) and inflammatory (MCP-1, IL-8, TNFα, IL-1β, IL-10, monocyte cell
surface markers CD11b/CD11c and VLA-4, expression of adhesion molecules VCAM-1 and ICAM-1 in
cultured human aortic endothelial cells) factors as well as blood pressure.
Not yet recruiting | Atherosclerosis | Not Multisite
Effects of Sitagliptin on Arterial Vasoreactivity and Proatherogenic Mediators in Obesity
Overview of Study Design: This is a double-masked, randomized, placebo-controlled pilot study
of treatment sitagliptin (100mg/day) to suppress monocyte/macrophage activation in obese
non-diabetic participants. 16 abdominally obese18-40 year-old largely minorities will be
randomized 3:1 to receive sitagliptin (N=12) or matching placebo (N=4) daily for 28 days.
Eligibility Criteria for the Study Cohort: Based on prior studies conducted by the
investigators, approximately 60-70% of participants enrolled will be Hispanics and African
Americans. Both minorities have increased prevalence of insulin resistance (IR) at young
ages. In their prior studies, insulin resistance (HOMA-IR* ≥3.0) had a predictive value of
88% for crown like structure in abdominal fat (a surrogate for fat inflammation); the
inclusion criterion for IR will assure that most study subjects will have abdominal fat
* homeostatic method of analysis-insulin resistance
1. Age 18-40 years of age
2. Stable weight (no change >3% in prior 6 months)
3. Waist circumference ≥102cm for men; ≥88cm for women
4. Fasting plasma glucose 100-125, HgbA1C 5.7-6.4% or HOMA-IR* ≥3.0
1. Regular use of a non-steroidal anti-inflammatory drug (NSAID); unwilling to stop NSAID
2. On statin or other prescription anti-inflammatory drugs
3. Diabetes or clinically evident cardiovascular disease
4. Smoking daily or consuming >200g alcohol/day
Study participants will be adults 18-40 years of age to exclude older persons with
irreversible atherosclerosis (e.g. calcified, stenotic plaque) or subclinical arterial
thrombus which release inflammatory mediators. Persons with Type 2 diabetes (a myocardial
infarction equivalent) and those receiving "statins" (also potent anti-inflammatory drugs)
will be excluded, thereby further excluding participants with advanced atherosclerosis. The
goal is to identify and study persons with abdominal obesity and inflammation at a younger
age as a potential target population for pre-emptive anti-inflammatory therapy to prevent
serious CVD events over ensuing years.
1. Change in arterial vasoreactivity measured and quantified by ultrasound assessment of
brachial artery flow mediated dilation and carotid stiffness (elasticity and
2. Change in measures of inflammation in intra-abdominal adipose tissue:
1. M1 pro-inflammatory macrophages and M2 anti-inflammatory macrophages by fluorescent
activated cell sorting.
2. Ex vivo secretion of inflammatory mediators from macrophages fractions.
3. Change in systemic pro-inflammatory/pro-atherogenic markers and insulin resistance.
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Evidence supporting a routine invasive practice paradigm for patients with stable ischemic
heart disease (SIHD) is outdated. In strategy trials conducted in the 1970s, coronary artery
bypass grafting (CABG) improved survival as compared with no CABG in SIHD patients with
high-risk anatomic features. The relevance of these studies today is speculative because
contemporary secondary prevention—aspirin, beta-blockers, statins, ACE inhibitors, and
lifestyle interventions—were used minimally if at all. Subsequent trials have compared
percutaneous coronary intervention (PCI) with medical therapy, as PCI has replaced CABG as
the dominant method of revascularization for SIHD. To date, PCI has not been shown to reduce
death or myocardial infarction (MI) compared with medical therapy in SIHD patients.
COURAGE and BARI 2D, the two largest trials comparing coronary revascularization vs. medical
therapy in SIHD patients, found that among patients selected on the basis of coronary
anatomy after cath, an initial management strategy of coronary revascularization (PCI, PCI
or CABG, respectively) did not reduce the primary endpoints of death or MI (COURAGE), or
death (BARI 2D) compared with OMT alone. These data suggest, but do not prove, that routine
cath--which often leads to ad hoc PCI through the diagnostic-therapeutic cascade--may not be
required in SIHD patients. However, most patients enrolled in COURAGE and BARI 2D who had
ischemia level documented at baseline had only mild or moderate ischemia, leaving open the
question of the appropriate role of cath and revascularization among higher risk patients
with more severe ischemia. Observational data suggest that revascularization of patients
with moderate-to-severe ischemia is associated with a lower mortality than medical therapy
alone, but such data cannot establish a cause and effect relationship. In clinical practice
only about half such patients are referred for cath, indicating equipoise. Furthermore,
analysis of outcomes for 468 COURAGE patients with moderate-to-severe ischemia at baseline
did not reveal a benefit from PCI. This issue cannot be resolved using available data
because all prior SIHD strategy trials enrolled patients after cath, introducing undefined
selection biases (e.g., highest risk patients not enrolled) and making translation of study
results problematic for clinicians managing patients who have not yet had cath.
A clinical trial in SIHD patients uniformly at higher risk (which could not have been
performed before COURAGE and BARI 2D results were available) is needed to inform optimal
management for such patients.
The study protocol is final, and was distributed to sites February 2012. Study protocol v2.0
was approved in January 2014.
- USA (~150 sites)
- Russian Federation
- New Zealand
- Saudi Arabia
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Prevention of stroke involves managing and treating risk factors. Most strokes are caused
when blood flow to a portion of the brain is blocked. One place this often happens is in the
carotid artery. This blockage is called atherosclerosis or hardening of the arteries.
The purpose of this trial is to determine the best way to prevent strokes in people who have
a high amount of blockage of their carotid artery but no stroke symptoms related to that
blockage. Each eligible participant will be evaluated to determine which procedure(s) is best
for him/her. All participants will receive intensive medical treatment. In addition,
participants will be randomized to receive the selected procedure or not.
The trial will be conducted in the United States and Canada by physicians carefully selected
on their ability to perform the procedures at low risk. Another key component of the trial is
that important stroke risk factors, including hypertension, diabetes, high cholesterol,
cigarette smoking, physical activity, and diet will be managed intensively. Participants will
remain in the study for 4 years.
The Robotic Vascular and Endovascular Registry (ROVER)
The objectives of the study are to allow the physician to use the commercially available
Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets
in the peripheral vasculature to:
- Determine the number of endovascular procedures consecutively performed with the
Magellan Robotic System to navigate to treatment targets in the peripheral vasculature
- Achieve stable and efficient system preparation and set-up times, navigation and
cannulation times of target vessels during endovascular procedures, and placement
of therapeutic equipment used to perform endovascular procedures.
- Achieve stable and reduced fluoroscopy time during the endovascular procedures.
- Determine the number of cases required to reach a "steady state," reduction or
predictable time in conducting peripheral interventional procedures using descriptive
(means, ranges) statistics to analyze the data.
This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially
enrolling data collection activity (for which Hansen Medical is providing funding). Only
patients scheduled to undergo endovascular procedures using the Magellan Robotic System will
be approached for enrollment.
Registry procedures will be conducted in accordance with the labeled indication for use of
the Magellan™ Robotic System.
Prior to the physician participating in the registry and prior to subject enrollment, all
participating physicians will be required to complete Hansen Medical's Magellan Robotic
Participating registry sites must have a commercially available Magellan Robotic System for
the treatment of patients.
Participating sites will be assigned a specific site numeric identification code by the
The information collected into the registry will be data related to the procedure in which
the Magellan System was used or planned to be used and may include patient follow-up data,
minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for
the resolution of a procedural or post procedure adverse event.
The database will be a repository for the collected registry data and the data will be made
available (in extractable format) to the physician participants.
The data submitted will be reviewed on a regular basis for safety issues and complaints.
Adverse events and/or complaints deemed reportable will be submitted to the appropriate
regulatory agency/agencies by Hansen Medical, Inc.
Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120
sites in the US and Europe. Control device will be any Abiomed Impella device approved for
use in high-risk PCI.
This clinical investigation is divided into two phases, a feasibility phase and a pivotal
- Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the
CIP versions 1-4 at 48 sites in the United States (U.S.) prior to January 30, 2017
- Pivotal Phase: Includes subjects to be registered under the current or later version of
the CIP at up to 120 sites in the U.S. and Europe
Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP; each operator must
treat a minimum of 1 and up to 2 subjects with the HeartMate PHP first before becoming
qualified to randomize subjects
Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1
ratio to the HeartMate PHP and Impella.
A Prospective, Multicenter, Single-arm Study Designed to Assess the Safety of 3-month Dual Antiplatelet Therapy (DAPT) in Subjects at High Risk for Bleeding Undergoing Percutaneous Coronary Intervention (PCI) With the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual
antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous
coronary intervention (PCI) with the SYNERGY Stent System.
The study will be conducted up to 120 sites worldwide in the United States, Europe, Japan,
and Brazil with planned enrollment of up to 2,250 subjects. Clinical follow-up will be
required at the following time points: 3 months, 6 months, 12 months and 15 months post index
Subjects must be treated with one of the following P2Y12 inhibitors (clopidogrel, prasugrel,
or ticagrelor) for 3 months following the index procedure. Subjects must be treated with
aspirin for the duration of the trial. The minimum daily maintenance dose of aspirin should
be 75-100 mg.
Subjects are eligible for discontinuation of P2Y12 inhibitor at 3 months if they meet both of
the following criteria: subject was treated with 3 months of study required antiplatelet
therapy post index procedure; and subject was free from events (stroke, MI, PCI, coronary
artery bypass graft [CABG], and stent thrombosis) between the index procedure and the 3 month
Subjects are not eligible for discontinuation of P2Y12 inhibitor at 3 months if any of the
following criteria are met: subject who experiences a stroke, MI, PCI, CABG and/or stent
thrombosis, during the 0-3 month period (between the date of the index procedure and the date
of the 3-month follow-up visit); or subject who is non-compliant with study required
antiplatelet therapy during the 0-3 month period (between the date of the index procedure and
the date of the 3-month follow-up visit); or subject judged inappropriate for discontinuation
from P2Y12 inhibitor use at 3 months due to another condition requiring chronic P2Y12
All enrolled subjects who receive a SYNERGY stent must be followed at all milestones through
15-months, regardless of eligibility to discontinue P2Y12 inhibitor. Following the 3-month
milestone, subjects who experience MI or stent thrombosis events should be treated per the
investigator's discretion and should be followed through the 15-month visit.
Active, not recruiting | Atherosclerosis | Multisite