Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

Official title

CRYSTAL Study: A Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

Overview

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)

Detailed 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.

Interventions

• Device MiStent II coronary artery stent
  Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
• Device Xience or Promus coronary artery stents
  Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction

Primary outcome measures

• Target Lesion Failure (TLF) [Time frame: through 12-month visit]

Secondary outcome measures (12)

• Device success [Time frame: Index Procedure]
• Technical success [Time frame: Index Procedure]
• Procedural success [Time frame: Index Procedure]
• Composite Endpoint POCE [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Composite Endpoint MACE [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Composite Endpoint TVF [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Composite Endpoint TLF [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Mortality [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Myocardial Infarction [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Revascularization [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Stent thrombosis rates [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]
• Serious Adverse Events (SAEs) [Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up]

Eligibility criteria

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:

• Stenosis ≥70% or;
• Abnormal fractional flow reserve (FFR) defined as <0.80 or;
• 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 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):

• 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, 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT03423511 · MIS-US-2017-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗