Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction (APPOSITION V)
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ClinicalTrials.gov Identifier: NCT01732341 |
Recruitment Status :
Terminated
(Decision to discontinue patient follow-up at 2 years.)
First Posted : November 22, 2012
Last Update Posted : April 20, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 2, 2012 | ||||||
First Posted Date ICMJE | November 22, 2012 | ||||||
Last Update Posted Date | April 20, 2017 | ||||||
Study Start Date ICMJE | May 2013 | ||||||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Target Vessel Failure [ Time Frame: 12 months. ] From date of randomization until the date of first documented TVF, assessed up to 12 months.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Acute Stent Malapposition [ Time Frame: Immediately after procedure ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction | ||||||
Official Title ICMJE | APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acute Myocardial Infarction | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Grundeken MJ, Lu H, Mehran R, Cutlip DE, Leon MB, Yeung A, Koch KT, Montalescot G, van Geuns RJ, Spaargaren R, Buchbinder M. APPOSITION V: STENTYS coronary stent system clinical trial in subjects with ST-segment elevation myocardial infarction--rationale and design. Am Heart J. 2014 Nov;168(5):652-60. doi: 10.1016/j.ahj.2014.07.011. Epub 2014 Jul 24. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
318 | ||||||
Original Estimated Enrollment ICMJE |
880 | ||||||
Actual Study Completion Date ICMJE | March 2017 | ||||||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: General Inclusion Criteria
Angiographic Inclusion Criteria
Exclusion Criteria: General Exclusion Criteria
Angiographic Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Netherlands, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01732341 | ||||||
Other Study ID Numbers ICMJE | STENTYS | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Stentys | ||||||
Study Sponsor ICMJE | Stentys | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Stentys | ||||||
Verification Date | November 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |