NCT01732341

Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Stentys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent is not worse than the Vision stent.

Detailed description

Coronary artery disease continues to be the most common cause of morbidity and mortality in the occidental world. Treatment of coronary atherosclerotic disease has been significantly advanced by interventional cardiology, and in particular the advent of coronary arterial stents. In comparison to angioplasty alone, stents have reduced the incidence of angiographic as well as clinical restenosis, the recurrence of angina, the need for coronary arterial bypass graft (CABG) surgery, the need for repeat revascularization and the occurrence of major adverse cardiac events (MACE).However,problems remain due to failure to achieve optimal stent apposition and normal myocardial reperfusion. Early stent malapposition may be due to incomplete expansion or undersizing of balloon-expandable stents. Several studies have emphasized the importance of early malapposition in the setting of ST elevation MI, in which substantial thrombotic burden and the presence of diffuse vasoconstriction may be contributory. The Stentys Coronary Stent System includes a self-expanding bare metal (nitinol) stent on a rapid exchange (RX) delivery system. In view of the theoretical implications of malapposition, the self-expanding property may offer a potential benefit. This study is designed to evaluate the safety and effectiveness of the Stentys Coronary Stent System in the treatment of de novo stenotic lesions in coronary arteries in patients undergoing primary revascularization due to AMI as compared to the Multi-Link Vision™ coronary stent system (Abbott Vascular Inc. The study is powered for non-inferiority of the Stentys Coronary Stent System compared to the Vision Stent System.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	STENTYS self-apposing stent	Intervention to treat STEMI with the STENTYS self-apposing stent
DEVICE	VISION balloon-expandable stent	STEMI treatment with a VISION balloon-expandable stent \--------------------------------------------------------------------------------

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2017-03-01
• First posted: 2012-11-22
• Last updated: 2017-04-20

Locations

3 sites across 2 countries: United States, Netherlands