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About
To compare MiStent to either the Xience or Promus stents.with the primary objective being to assess the safety and efficacy of the MiStent in a patient population requiring revascularization of de novo obstructive lesions of coronary arteries in patients with stable and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction (NSTEMI)
Full description
The CRYSTAL study is a prospective, multi-center, randomized (1:1), single-blinded and controlled, investigational device exemption trial to test the non-inferiority of MiStent to commercially available "everolimus" drug eluting stents (Xience and Promus stents).
Patients with coronary artery disease (CAD) that qualify for percutaneous coronary intervention (PCI) with stenting will be screened per the protocol inclusion and exclusion criteria.
Enrollment
Sex
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Volunteers
Inclusion criteria
Subject must be ≥ 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)
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) ≥2.50 mm and ≤3.50 mm
Target lesion(s) must be able to be treated with a single stent and the target lesion length must be ≤27 mm (by visual estimate).
NOTE: Only lesion lengths that have both the control and comparable investigational stent lengths available at the same time are eligible for enrollment.
Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:
Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
The first lesion treated must be successfully predilated/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 in the target vessel(s)
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., Cobalt-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 the index procedure):
Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) 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 glomerular filtration rate (GFR) of <30 ml/min
Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, 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 severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) <30%))
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 a single lesion with more than 1 stent
Planned treatment of more than 3 lesions
Planned treatment of lesions in more than 2 major epicardial vessels
Planned treatment of more than 2 lesions in a single major epicardial vessel
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 or unprotected left
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 been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
Significant thrombus, present in the target vessel (by visual estimate)
Primary purpose
Allocation
Interventional model
Masking
1,300 participants in 2 patient groups
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Central trial contact
Christopher DiMatteo; Jeffrey Mifek
Data sourced from clinicaltrials.gov
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