NCT01787799

Brief Summary

The purpose of this study is to evaluate 9 month angiographic and intravascular ultrasound (IVUS) data for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2016

Completed
Last Updated

March 16, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

January 16, 2013

Results QC Date

January 6, 2016

Last Update Submit

February 18, 2016

Conditions

Atherosclerotic Lesion(s)

Keywords

Drug-eluting stents

Outcome Measures

Primary Outcomes (1)

  • In-stent Late Loss

    In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)

    9 month

Study Arms (1)

SYNERGY Stent System

EXPERIMENTAL

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)

Device: SYNERGY

Interventions

SYNERGYDEVICE

Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.

SYNERGY Stent System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 18 years of age
  • Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
  • For subjects less than 20 years of age enrolled at a Japanese site, the subject and the subject's legal representative must provide written informed consent before any study-specific tests or procedures are performed
  • Subject is eligible for percutaneous coronary intervention (PCI)
  • Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
  • Subject is willing to comply with all protocol-required follow-up evaluation
  • Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
  • Target lesion(s) length must be ≤34 mm (by visual estimate)
  • Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure)
  • Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
  • The first lesion treated must be successfully pre-dilated/pretreated

You may not qualify if:

  • Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
  • Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
  • 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
  • Planned PCI (including staged procedures) or CABG after the index procedure
  • Subject previously treated at any time with intravascular brachytherapy
  • Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors (clopidogrel, ticlopidine, prasugrel, or ticagrelor), or aspirin)
  • Subject has one of the following (as assessed prior to the index procedure):
  • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of 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 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, including laboratory evidence of hepatitis
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Monash Medical Centre-Clayton Campus

Clayton, Victoria, 3168, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3085, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, 247-8533, Japan

Location

Mercy Angiography Unit, Ltd.

Auckland, 1003, New Zealand

Location

Auckland City Hospital

Auckland, 1010, New Zealand

Location

Ascot Angiography Ltd

Auckland, 1050, New Zealand

Location

Middlemore Hospital

Auckland, 1640, New Zealand

Location

North Shore Hospital

Auckland, 622, New Zealand

Location

Christchurch Hospital NZ

Christchurch, 8011, New Zealand

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre

Singapore, 168752, Singapore

Location

Results Point of Contact

Title
Peter Maurer, MPH; Director of Clinical Trials
Organization
Boston Scientific
peter.maurer@bsci.com
508-683-6678

Study Officials

  • Ian Meredith, Professor

    Monash Medical Centre-Clayton Campus, 246 Clayton Road, 3168 Clayton, Victoria, Australia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

February 11, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

March 16, 2016

Results First Posted

March 16, 2016

Record last verified: 2016-02

Locations

SG(2)AU(4)NZ(6)JP(1)