Status:
COMPLETED
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent Syst...
Eligibility Criteria
Inclusion
- Clinical 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
- Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for coronary artery bypass grafting (CABG)
- Subject has either:
- Symptomatic coronary artery disease with one of the following: stenosis ≥ 70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
- OR
- Documented silent ischemia based on one of the following: abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
- Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria (visual estimate)
- Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.5 mm and ≤4.0 mm
- Target lesion length must be \>34 mm and ≤44 mm (by visual estimate)
- Target lesion must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1
- Coronary anatomy is likely to allow delivery of a study device to the target lesion
- The target lesion must be successfully predilated/pretreated. If a non-target lesion is treated, it should be treated first and should be deemed an angiographic success Note: Angiographic success is a mean lesion diameter stenosis \< 50% (\< 30% for stents) in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
- Note: Successful predilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.
- Clinical 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, or aspirin)
- Subject has one of the following (as assessed prior to enrollment):
- 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 signs or symptoms of active heart failure (i.e., New York Heart Association (NYHA) class IV) at the time of the index procedure
- 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 Angiographic Exclusion Criteria (visual estimate)
- Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 study stent
- Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in the target vessel and 1 non-target lesion in non-target vessel is allowed
- 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)
- Target lesion meets any of the following criteria:
- Treatment of a single lesion with more than 1 stent
- Left main location
- Lesion 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
- Lesion is located within a saphenous vein graft or an arterial graft
- Lesion will be accessed via a saphenous vein graft or arterial graft
- Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Lesion treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- Lesion is restenotic from a previous stent implantation or study stent would overlap with a previous stent
- Non-target lesion meets any of the following criteria:
- Located within the target vessel
- Left main location
- Lesion is located within a saphenous vein graft or an arterial graft
- Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Lesion treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
- Requires additional unplanned stents (treatment of the non-target lesion with more than one stent is permitted as long as the stents are initially planned)
- Treatment not deemed an angiographic success Note: Angiographic success is a mean lesion diameter stenosis \< 50% (\< 30% for stents) in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
Exclusion
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03350542
Start Date
April 12 2018
End Date
January 8 2021
Last Update
May 14 2021
Active Locations (15)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
3
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, United States, 10032
4
Rex Hospital
Raleigh, North Carolina, United States, 27607