Phase 3
Completed N=100
EVOLVE II QCA: A Prospective, Multicenter Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
Atherosclerotic Lesion(s)
Source: ClinicalTrials.gov NCT01787799 ↗
Enrolled (actual)
100
Serious AEs
38.0%
Results posted
Mar 2016
Primary outcomePrimary: In-stent Late Loss — 0.23 mm
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Loss |
0.23 | — |
Eligibility 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 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 700, 000 cells/mm3
- Subject has a white blood cell (WBC) count 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 co
Data sourced from ClinicalTrials.gov (NCT01787799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.