A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction

Launched by DEUTSCHES HERZZENTRUM MUENCHEN · Sep 10, 2013

Keywords

ClinConnect Summary

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 inn...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
• • 2. Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
• • 3. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
• • 4. In women with childbearing potential a negative pregnancy test is mandatory
• Exclusion Criteria:
• • 1. Target lesion located in the left main trunk
• • 2. Severely calcified lesions
• • 3. Bifurcation lesions with side branch diameter \> 2mm
• • 4. In-stent restenosis
• • 5. Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
• • 6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
• • 7. Pregnancy (present, suspected or planned) or positive pregnancy test.
• • 8. Previous enrolment in this trial
• • 9. Patient's inability to fully cooperate with the study protocol