Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease (ALEX OCT)

Balton

Status and phase

Completed

Phase 4

Conditions

Unstable Angina

Stable Angina

Myocardial Infarction

Treatments

Procedure: Implantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01637012

2.0, 2011-12-01

Details and patient eligibility

About

To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Full description

Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical Inclusion Criteria:

> 18 years of age
Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee
clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels
earlier effective supply of others lesions in others vessels in case of multivessels disease
female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment

Angiographic Inclusion Criteria

target lesion stentosis must be > 70% (visual estimate)
Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)

Exclusion criteria

Clinical Exclusion Criteria

anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
acute or chronic renal failure (serum creatinine > 2 mg%, GFR < 60 ml/min/1.73m2)
left ventricular ejection fraction (LVEF) < 40%
cardiogenic shock
short life expectancy (< 1 year)
any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints

Angiographic Exclusion Criteria

chronic total occlusion
calcified lesion which cannot be successfully dilated
location of lesions in the winding vessels where there is no possibility of OCT imaging
target stenosis located in venous or arterial bridge
unprotected left main coronary disease with > 50% stenosis