Acute Myocardial Infarction
Conditions
Keywords
STEMI, BMS, Self-expanding stent
Brief 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.
Interventions
DEVICESTENTYS self-apposing stent
Intervention to treat STEMI with the STENTYS self-apposing stent
DEVICEVISION balloon-expandable stent
STEMI treatment with a VISION balloon-expandable stent \--------------------------------------------------------------------------------
Sponsors
Stentys
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Subject ≥ 18 years old. 2. Subject experiencing clinical symptoms consistent with AMI of \>30 min. in duration. 3. ST elevation ≥1 mm in ≥2 contiguous leads or new left bundle branch block, or true posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads. 4. Symptom duration is \<12 hours prior to signing informed consent. 5. Subject should be in catheterization laboratory and procedure started within 2 hours of consent. 6. Patient provides written informed consent. 7. Patient agrees to all required follow-up procedures and visits. Angiographic Inclusion Criteria 1. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting. 2. The vessel diameter is either known or expected to be 2.5-4.0mm, without excessive tortuosity or diffuse distal disease. 3. Lesion length ≥12mm and ≤ 23mm \-
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure | 12 months. | From date of randomization until the date of first documented TVF, assessed up to 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Acute Stent Malapposition | Immediately after procedure |
Countries
Netherlands, United States
Outcome results
None listed