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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,300
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
Target Lesion Failure (TLF)
Any occurrence of Target Lesion Failure (TLF) TLF is defined as: Cardiac death, or Target vessel myocardial infarction (TV-MI, Q-wave and non Q-wave), or Ischemia driven target lesion revascularization.
Time frame: through 12-month visit
Device success
Successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization with post procedure diameter stenosis of \< 30% (by visual estimation) in the Target Lesion.
Time frame: Index Procedure
Technical success
Achieving a final diameter stenosis of \<30% (by visual estimation) in the target lesion using any combination of stents or devices allowed per protocol.
Time frame: Index Procedure
Procedural success
Post-procedure diameter stenosis \<30% (by visual estimation) in all target lesions and the absence of in-hospital MI, TVR, or cardiac death.
Time frame: Index Procedure
Composite Endpoint POCE
POCE defined as all-cause death, any MI, or any revascularization
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint MACE
MACE defined as all-cause death, any MI, or any TVR
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TVF
TVF defined as cardiac death, TV MI, or clinically indicated TVR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Composite Endpoint TLF
TLF defined as cardiac death, TV MI or Ischemia driven TLR
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Mortality
Mortality including All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Myocardial Infarction
Myocardial Infarction including All MI, TV-MI, and Non-TV-MI
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Revascularization
Revascularization including Target Lesion revascularization (TLR) (any, clinically- indicated TLR, non-clinically indicated TLR), Target Vessel revascularization (TVR) (any, clinically- indicated TVR, non-clinically indicated TVR), Non-TV revascularization, and Any revascularization
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Stent thrombosis rates
Stent thrombosis rates according to ARC classification: ST - Early (Acute, Sub-acute), Late, Very Late; ST - Definite, Probable, Possible
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up
Serious Adverse Events (SAEs)
* All SAEs through 12 months' post-index procedure * All device related SAEs from 12 months through 5 years' post-index procedure
Time frame: prior to discharge, at 1-, 6- and 12-months and annually thereafter through 5 years' follow-up