- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787799
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) (EVOLVE II QCA)
February 18, 2016 updated by: Boston Scientific Corporation
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)
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre-Clayton Campus
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Fitzroy, Victoria, Australia, 3085
- St Vincent's Hospital Melbourne
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Fremantle Hospital
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Kanagawa
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Kamakura-shi, Kanagawa, Japan, 247-8533
- Shonan Kamakura General Hospital
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Auckland, New Zealand, 1640
- Middlemore Hospital
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Auckland, New Zealand, 1010
- Auckland City Hospital
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Auckland, New Zealand, 1050
- Ascot Angiography Ltd
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Auckland, New Zealand, 622
- North Shore Hospital
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Auckland, New Zealand, 1003
- Mercy Angiography Unit, Ltd.
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Christchurch, New Zealand, 8011
- Christchurch Hospital NZ
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Singapore, Singapore, 119074
- National University Hospital
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Singapore, Singapore, 168752
- National Heart Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SYNERGY Stent System
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-stent Late Loss
Time Frame: 9 month
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In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
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9 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian Meredith, Professor, Monash Medical Centre-Clayton Campus, 246 Clayton Road, 3168 Clayton, Victoria, Australia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 16, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 11, 2013
Study Record Updates
Last Update Posted (Estimate)
March 16, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S2072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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