NCT01637012

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

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. Study With Angiography and OCT Follow-up.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Balton Sp.zo.o. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Stable Angina
• Unstable Angina
• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Implantation	index angioplasty with ALEX stent implatation

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-07-10
• Last updated: 2014-03-13

Locations

5 sites across 1 country: Poland