Trials / Unknown
UnknownNCT01942070
A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 262 (actual)
- Sponsor
- Deutsches Herzzentrum Muenchen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
Detailed description
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently represents the dominant treatment strategy in patients undergoing catheter intervention. However effective neointimal suppression occurs at the cost of a systematic delay in arterial healing in comparison with after bare metal stenting. This underlies a small but significant increased risk of stent thrombosis after DES implantation in comparison with bare metal stent implantation as well as a possible excess of in-stent neoatheroma formation. Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing short-term vessel scaffolding and drug delivery without the long-term limitations of metallic DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent bypass grafting of the stented arterial segment. In addition preliminary reports suggest that the process of scaffold biodegradation may promote formation of a cohesive tissue layer covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing effect. Although initial results with BVS are encouraging, there is a lack of randomized clinical trial data and no data exists for outcomes after BVS implantation in patients undergoing coronary stenting in the setting of acute myocardial infarction (MI). The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bioresorbable vascular scaffold | |
| DEVICE | Durable polymer everolimus-eluting metallic stent |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2018-03-01
- Completion
- 2019-03-01
- First posted
- 2013-09-13
- Last updated
- 2018-07-09
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01942070. Inclusion in this directory is not an endorsement.