PROTECT Continued Access Post Marketing Surveillance Trial

Overview

In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").

This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Eluting Coronary Stent System. Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis and the clinical need for repeat revascularization frequently observed with bare metal stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the occurrence of late stent thrombosis (\> 30 days after stent implantation)12-14. Although the incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with stent thrombosis, and the soaring number of stents implanted annually, make it a significant medical problem. The purpose of this trial was to investigate the long-term clinical safety and efficacy of the Endeavor drug eluting stent in a large and higher risk patient population, which more closely reflects clinical practice today. Both unstable and stable patients with single or multivessel disease and complex lesions were eligible for enrollment. The selected primary endpoint was stent thrombosis, defined as definite and probable stent thrombosis according to the ARC definition, at 3 years. The main secondary endpoints were the composite of death or cardiac death combined with large or all non-fatal myocardial infarction, which are the typical clinical manifestations of stent thrombosis. These events are adjudicated by a clinical events committee. 1.2 Study Endpoints 1.2.1 Primary Endpoint: The overall stent thrombosis rate defined as definite and probable stent thrombosis according to the ARC definition at 3 years 1.2.2 Secondary Endpoints: Main Secondary Endpoints include: * Composite endpoint of total death and number of patients with all non-fatal myocardial infarction at 3 years * Composite endpoint of cardiac death and number of patients with all non-fatal myocardial infarction at 3 years * Composite endpoint of total death and number of patients with large non-fatal myocardial infarction at 3 years * Composite endpoint of cardiac death and number of patients with large non-fatal myocardial infarction at 3 years Additional secondary endpoints include: * Total Death and subcategories of Death * Large and all Myocardial Infarction (MI) * Stent thrombosis defined as definite, probable and possible * Composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) \* * Major Adverse Cardiac and Cerebral Events (MACCE) * Stroke (hemorrhagic in nature while on clopidogrel) * Bleeding complications in general * Target lesion revascularization (TLR) * Target vessel revascularization (TVR) * Non target vessel revascularization (non TVR) * Procedural success * Device success * Lesion success * Endpoints will be calculated at the follow-up time points and for the mean follow-up period. * The composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) constructed from a patient population according to the Delphi method.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes