EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Medstar Research Institute
Quintiles
Medidata Solutions
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01787799
First received: January 16, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Atherosclerotic Lesion(s)
Device: SYNERGY
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Trial 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)

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • In-stent late loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)


Secondary Outcome Measures:
  • Target lesion revascularization (TLR) rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Target lesion failure (TLF) rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel failure (TVF) rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • All revascularization rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Myocardial infarction (MI) rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
    Q-wave and non-Q-wave

  • Cardiac death rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Non-cardiac death rate [ Time Frame: 30 days. 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • All death rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Cardiac death or MI rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • All death or MI rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • All death/MI/TVR rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis rates [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
    by Academic Research Consortium [ARC] definitions

  • Stroke rate [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: Yes ]
    ischemic and hemorrhagic

  • Longitudinal stent deformation rate assessed by an independent angiographic core laboratory [ Time Frame: 30 days, 9 months, 12 months ] [ Designated as safety issue: No ]
  • Technical success rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: No ]
    Technical success is successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician.

  • Clinical procedural success rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: Yes ]
    Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.

  • In-stent and in-segment percent diameter stenosis (%DS) measured by QCA [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: No ]
    QCA will be done by an external Lab, but the angio used for the QCA is done during procedure.

  • In-stent and in-segment minimum lumen diameter (MLD) measured by QCA [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: No ]
    QCA will be done by an external Lab, but the angio used for the QCA is done during procedure.

  • In-stent and in-segment acute gain measured by QCA [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: No ]
    QCA will be done by an external Lab, but the angio used for the QCA is done during procedure.

  • Longitudinal stent deformation rate by QCA [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day. ] [ Designated as safety issue: No ]
    QCA will be done by an external Lab, but the angio used for the QCA is done during procedure.

  • In-stent and in-segment %DS [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Measured by QCA

  • In-segment late loss [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    QCA

  • In-stent and in-segment binary restenosis rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    QCA

  • In-stent and in-segment MLD [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    QCA

  • Stent fracture rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    QCA

  • Longitudinal stent deformation rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    QCA

  • Incomplete apposition [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    IVUS

  • Percent net volume obstruction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    IVUS

  • Stent, vessel and lumen area volumes [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    IVUS


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
Device: SYNERGY
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Angiographic Inclusion Criteria (visual estimate)

  • 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

Exclusion Criteria:

  • 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
  • Subject is on dialysis or has baseline serum creatinine level >2.0 mg/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 severe symptomatic heart failure (i.e., New York Heart Association (NYHA) class IV)
  • Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
  • Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
  • Subject 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)

Angiographic Exclusion Criteria (visual estimate)

Planned treatment of more than 3 lesions

  • Planned treatment of lesions in more than 2 major epicardial vessels
  • Planned treatment of a single lesion with more than 1 stent
  • Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
  • Target lesion(s) is located in the left main
  • Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.
  • Target lesion(s) is located within a saphenous vein graft or an arterial graft
  • Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
  • Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
  • Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
  • Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
  • Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
  • Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787799

Locations
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
Monash Medical Centre-Clayton Campus
Clayton, Victoria, Australia, 3168
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3085
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan, 247-8533
New Zealand
North Shore Hospital
Auckland, New Zealand, 622
Middlemore Hospital
Auckland, New Zealand, 1640
Ascot Angiography Ltd
Auckland, New Zealand, 1050
Auckland City Hospital
Auckland, New Zealand, 1010
Mercy Angiography Unit, Ltd.
Auckland, New Zealand, 1003
Christchurch Hospital NZ
Christchurch, New Zealand, 8011
Singapore
National Heart Centre
Singapore, Singapore, 168752
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
Boston Scientific Corporation
Beth Israel Deaconess Medical Center
Medstar Research Institute
Quintiles
Medidata Solutions
Investigators
Principal Investigator: Ian Meredith, Professor Monash Medical Centre-Clayton Campus, 246 Clayton Road, 3168 Clayton, Victoria, Australia
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01787799     History of Changes
Other Study ID Numbers: S2072
Study First Received: January 16, 2013
Last Updated: December 11, 2013
Health Authority: Australia: National Health and Medical Research Council
New Zealand: Ministry of Health
Singapore: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Boston Scientific Corporation:
Drug-eluting stents

Additional relevant MeSH terms:
Chromium
Everolimus
Sirolimus
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014