Status and phase
Conditions
Treatments
About
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 System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
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):
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.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal